UK Government Responds to Brexit Life Sciences Regulatory Recommendations

The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report on “Brexit: Medicines, Medical Devices and Substance of Human Origin”, which considered the regulatory arrangements needed for the safe and effective supply of medicines and medical devices post-Brexit.

The response states that:

• The safety of patients is of paramount importance to the UK Government’s exit negotiations and that it is preparing for all potential outcomes but is “increasingly confident that the prospect of a ‘no deal’ scenario is highly unlikely”.
• The Government recognises the importance of a close and cooperative relationship between the UK and EU in relation to medicines and devices regulation and it wants to explore the terms on which the UK could remain part of EU agencies, including the European Medicines Agency (EMA).
• Under the terms of the implementation period (from the UK leaving the EU in March 2019 until the end of 2020), the UK will no longer be an EU Member State but businesses will be able to trade on the same terms as now until the end of 2020. This includes the EU continuing to accept UK batch testing, release and inspections, UK-based Marketing Authorisation Holders (MAH) and other key roles including QP certification.
• During the implementation period, the current EU principles and guidelines of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) will continue to apply in the UK. There is no current policy intention for any divergence, though the UK MHRA will have the power to update these principles and guidelines in the future to reflect evolving best practice.
• In relation to goods, including medicines and devices, the Government’s position is that the UK-EU border should be as frictionless as possible and products should only need to undergo one set of approvals to be sold in both the EU and UK.
• The UK Department of Health and Social Care (DHSC) is currently assessing the impact of Brexit on the supply chain for all medicines and devices used in the National Health Service (NHS).
• UK citizens participating in on-going trials in the UK will not be affected by the UK’s exit from the EU or the end of the implementation period.

U.K. Government to Review the use of Medicinal Cannabis

The U.K. governemnt is to carry out a review of the scheduling of cannabis for medicinal use.

Home Secretary, Sajid Javid, said a commission would first ask experts look at the evidence for the medical benefits of cannabis, and then government advisors would recommend what products might be rescheduled.

But he underlined that there is no question of the government legalising cannabis for recreational use, saying penalties for unauthorised supply and possession will remain in place.

The issue has been thrust to the forefront of political debate after the mother of 12-year-old Billy Caldwell, demanded a law change when the cannabis oil she was carrying to treat her son’s epilepsy, was confiscated at Heathrow Airport, on her return from Canada

Under current laws, doctors in the U.K. who prescribe cannabis oil for epilepsy can be sentenced to up to 14 years in prison.

Mr Javid told Parliament; “it has become clear to me since becoming home secretary that the position we find ourselves in currently is not satisfactory. It is not satisfactory for the parent, it’s not satisfactory for the doctors and it is not satisfactory for me. I’ve now come to the conclusion that it is time to review the scheduling of cannabis.”

Mr Javid explained that part one of the commission will review evidence for the benefits of a range of cannabis based medicines led by Professor Dame Sally Davies, the chief medical officer.

Pfizer wins U.K. appeal on £84M price hike fine

Following a record fine by the UK Competition and Markets Authority, over a 2,600% drug price hike drug price hike, Pfizer has won its appeal.

The case involved Pfizer, distributor Flynn Pharma and epilepsy drug Epanutin. The U.K.’s Competition and Markets Authority (CMA) fined the companies a total of £90 million after it ruled they charged unfair prices through a scheme to “debrand” the drug. Pfizer’s share of the fine was £84 million ($112 million).

CMA argued that Epanutin was under price controls as a branded medication and that it licensed the drug to Flynn Pharma, as a generic, thereby circumventing the price stricture. Under the supply agreement, Pfizer manufactured Epanutin and the CMA claimed that Flynn paid Pfizer more than Pfizer could charge for its branded version, resulting in an immediate price rise to £67.50 from £2.83 for an 84-pack of 100mg capsules.

However, the Competition Appeal Tribunal has ruled that CMA’s decision was flawed because the CMA “did not correctly apply the legal test for finding that prices were unfair”

Pfizer said it was “pleased” with the decision while the CMA said it is considering an appeal. The CMA has several pharmaceutical reviews underway and says they may now be “severely delayed.”

Lundbeck in $52.6M settlement with U.S. DoJ

Denmark’s neuro drug firm, Lundbeck has disclosed an “agreement in principle” with the U.S. Department of Justice whereby it will pay $52.6 million to resolve an investigation into its relationship with and donations to patient assistance charities. The agreement and settlement is on a no fault basis but Lundbeck did advise that the settlement is subject to further negotiation.

Lundbeck disclosed that the U.S. Attorney’s Office in Boston subpoenaed the company in May 2016 as part of an investigation into charity groups and marketing practices.

Lundbeck is among a group of industry players under investigation for contributions to patient assistance charities.

Other companies involved in the probe include Johnson & Johnson, Astellas, Gilead Sciences, Celgene and Biogen while Jazz Pharmaceuticals reached a tentative $57 million agreement in April and United Therapeutics agreed a $210 million settlement with U.S. authorities.

Pharma companies can donate to charity groups but only on the proviso that the charities remain independent and are not merely a “conduit” for boosting drug sales.

Q1 2018: Europe

MHRA changes licence for valproate medicines

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines, so that they can no longer be prescribed to females of child-bearing age unless they are on the pregnancy prevention programme (PPP).

Valproate – which is available on the UK market as Epilim, Depakote and generic brands – is an effective treatment for epilepsy and bipolar disorder.

However, children born to women who take the drug during pregnancy are at significant risk of birth defects (around 10 percent) and persistent developmental disorders (up to four in 10), the regulator stressed.

Going forward, healthcare professionals wishing to prescribe valproate must ensure that female patients of child-bearing age are enrolled in the PPP, which includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, at least annually.

These regulatory changes, which are designed to protect public health, will be further supported in the upcoming months by smaller pack sizes to encourage monthly prescribing and a pictogram/warning image on valproate labelling, the MHRA noted.

EMA rejects AB Science’s ALS drug

The European Medicine Agency’s has rejected approval of AB Science masitinib for amyotrophic lateral sclerosis.

ALS, aka Lou Gehrig’s disease, is a rare degenerative disorder that causes muscle wasting and progressive paralysis.

The Committee for Medicinal Products for Human Use said reliability of the data provided in the submission was not robust enough to support a registration, based on a Good Clinical Practice inspection at two of the main clinical study sites.

It also failed to recognise the clinical relevance of the distinction made by AB Science between patients with “normal” progression (accounting for 85 percent of patients in the study) and for whom an improvement on the primary endpoint – ALSFRS score – has been demonstrated, and those with “rapid” progression (accounting for 15 percent of patients in the study), the firm noted.

The company has requested a re-examination of the decision, and said it would provide further analyses to address its concerns. A second opinion from the CHMP on the drug, which carried orphan status in both the US and EU, is expected in July.

Pharma Industry welcomes progress on Brexit

Pharmaceutical industry representatives have welcomed the decision to progress Brexit negotiations to the next phase, with the UK and EU having agreed the terms of the transition period.

The 21-month transitional period will run from March 29, 2019 to the end of 2020, during which time rights for EU citizens arriving in the UK will remain as per the status quo, as will those of UK citizens living in Europe.

During the period the UK will be allowed to negotiate new trade deals while remaining part of any EU trade deals already in place.

“The EU Council’s agreement to progress to future partnership talks and their approval of a transition period is welcome news,” said Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry.

“Every month, our industry supplies 45 million packs of medicine to Europe and 37 million come back the other way. Subject to the final withdrawal agreement, our members now know they will have until December 2020 to do all they can to make sure that these medicines continue to get to patients.”

Prime Minister Theresa May recently revealed the desire for the UK to remain part of the EMA following its departure from the European Union, saying that the government will “explore with the EU the terms on which the UK could remain part of EU agencies such as those that are critical for the chemicals, medicines and aerospace industries”.

Q1 2018: USA and Rest of World

$200M Merck award overturned in Gilead patent case

In a hepatitis C patent dispute between Merck & Co. and Gilead Sciences, an appeals court confirmed the decision of a lower court, that Merck is not entitled to a $200 million jury award because its lawyer’s misbehaviour “infected the entire lawsuit.”

The U.S. Court of Appeals for the Federal Circuit, which handles patent appeals, upheld a lower court’s ruling that Merck had “unclean hands” in the hep C patent fight. Though a federal jury in California had awarded $200 million to Merck, the judge in the case, struck down that verdict because she found a “pervasive pattern of misconduct” by Merck.

In an opinion this week, the appeals court outlined those misdeeds. A former Merck scientist and patent attorney, Phillipe Durette, learned of a Pharmasset hep C drug structure during a 2003 conference call between the companies. Durette then altered a Merck patent application, the court found.

Dr. Durette’s participation in that conference call violated a “firewall” the companies had set up to ensure that participants weren’t involved in patent applications.

During the court proceedings, Dr. Durette denied participating in the phone conference. He later backtracked and admitted he did. The scientist downplayed the knowledge he gained during the teleconference and its influence on the patent application, but the district court was not persuaded.

9 in 9: Gardasil gets fast-tracked in China

Only 9 days into its Gardasil 9 review, China’s drug regulator handed Merck’s HPV vaccine a conditional approval.

China’s Food and Drug Administration based its decision on Gardasil data that previously led to the quadrivalent shot’s Chinese approval last May, and for the latest approval, considered foreign clinical trial data specifically on Gardasil 9. The conditional approval comes with requirements for additional studies and postmarketing surveillance.

Doctor faces jail in Warner Chilcott’s marketing probe

Years after federal officials failed to win a guilty verdict against former Warner Chilcott president W. Carl Reichel, a doctor involved in the case has been less fortunate.

Rita Luthra, M.D., has been convicted for lying to investigators.

A federal jury in Massachusetts has convicted Luthra of allowing a Warner sales representative access to patient records and denying her ties to the company during an investigation.

In 2010, a Warner Chilcott representative asked Luthra to be a paid speaker and hold “med ed” events in her office, prosecutors said. No other healthcare providers attended the educational events.

For about 30 of those events, the company paid Luthra $23,500 in fees. While the government didn’t secure a conviction of accepting kickbacks, a jury found that the doctor illegally allowed the representative to look at patient data.

The court hasn’t yet scheduled her sentencing but an obstruction of justice charge carries a penalty of up to five years in prison, three years of supervised release and a fine of up to $250,000.

FDA restarts review of Nuplazid after hundreds of deaths

The FDA is reviewing the safety numbers on Acadia Pharmaceuticals’ antipsychotic drug Nuplazid after reports of side effects—including deaths—raised questions about its approval two years ago.

The review comes amid a surge of criticism for Nuplazid, prompted in part by a CNN April that said hundreds of patients died after receiving the drug for Parkinson’s-related psychosis.

It’s not the first time Acadia has faced questions about Nuplazid’s safety. A November analysis by the Institute for Safe Medication Practices documented 244 deaths between Nuplazid’s launch in June 2016 and March 2017. In total, the FDA has tracked more than 700 deaths after patients received the drug.

December 2017

E.U. Closes Infringement Procedure against Roche

The European Commission has has closed the infringement procedure taken against Roche for failure to meet certain pharmacovigilance obligations. The Commission explained that after considering all the available evidence and being satisfied with the company’s remedial actions, it has decided to close the case.

The infringement procedure was started by the European Medicines Agency (EMA) in October 2012, following an inspection carried out in 2012 by the MHRA which identified serious shortcomings in the the pharmacovigilance processes of Roche.

The aim of the inquiry was to investigate allegations that Roche failed to comply with its pharmacovigilance obligations in relation to 19 of its centrally authorised products.

In a written statement submitted to the Commission, Roche said:

“Roche accepted all the inspection findings. It took them extremely seriously and fully understands the EMA’s and Commission’s concerns. It has worked diligently to remediate the deficiencies as quickly as possible and also to enhance the company’s medical compliance and PV systems to prevent any recurrence”.

U.K. NICE rejects Eisai’s Halaven for earlier use but better news for Novartis and Pfizer

The UK’s price watchdog NICE has rejected Eisai’s cancer drug Halaven for earlier use.

Halaven was was approved last year by NICE to treat breast cancer patients after two rounds of chemo but the Japanese company was hoping for approval for earlier use. In its draft guidance, NICE said that Halaven was too expensive for use in patients with locally advanced or secondary breast cancer who have had only one chemotherapy treatment.

It noted that Halaven met its criteria to be considered an end-of-life treatment and added an average of 4.6 months to the survival of patients compared with chemo alone. However, it said the Eisai drug didn’t increase the time during which the tumour doesn’t grow thereby leaving a doubt about whether improved survival was attributable to the drug itself or to the treatments that followed use of Halaven.

In the cost range from from £36,244 to £82,743 ($48,000 to $110,000) per quality-adjusted year, the NICE Committee deemed it outside of what is normally considered acceptable for end-of-life treatments.

J&J and Bayer lose with $28M Xarelto verdict

A jury in Philadelphia has ordered Bayer and Johnson & Johnson to pay $28 million to plaintiff Lynn Hartman, after Harman’s lawyers argued that her Xarelto blood thinning regime caused severe gastrointestinal bleeding.

After 3 successful Xarelto defence cases in Louisiana and Mississippi, this is its first defeat. However, the drugmakers say they plan to appeal.

The Hartman case centred on whether physicians were properly instructed about the risks but J&J and Bayer contend that the Xarelto label does so. A Janssen spokesperson, said the “verdict contradicts years of scientific data and the U.S. Food and Drug Administration’s repeated confirmation of Xarleto’s safety and efficacy.”

Nonetheless, the company faces over 20,000 other liability cases.

Xarelto was granted FDA approval in 2011 and was Bayer’s top-selling drug last year, delivering $3.24 billion in sales and $2.5 billion for J&J.

Roche sues Pfizer for biosim patent infringement

Roche is suing Pfizer for infringement of 40 patents protecting its cancer drug, Herceptin.

In a complaint in Delaware federal court, Roche claims that Pfizer’s FDA application for its proposed biosim amounts to patent infringement and is seeking to block any potential launch.

Roche says it has spent “over two decades, and billions of dollars, developing Herceptin into the life-saving drug it is today” and it claims that Pfizer is using Roche studies to shortcut and prove safety and efficacy.

The FDA accepted Pfizer’s application in August but Pfizer has not yet secured approval for its Herceptin biosim.

Herceptin generated $2.5 billion for Roche in the U.S. last year but some of its patent protections lapse in 2019.

Europharma’s loses its GMP certification in Denmark

The Danish Medicines Agency (DMHA) has withdrawn Europharma’s GMP licence.

The DMHA statement of non-compliance stated that the nature of non-compliance is a general lack of will and ability to adhere to the principals of good manufacturing and good distribution practices as well as examples of non-adherence by Europharma.

FDA warns Amherst and Magna over “false or misleading” claims

The FDA’s Office of Prescription Drug Promotion has issued its third waring of the year so far. This time it was Amherst and Magna Pharmaceuticals were reprimanded for making “false or misleading” website and trade show claims about their insomnia treatment – Zolpimist.

In a letter, the FDA says that online and trade exhibition panels webpage failed to communicate any risk information and that claims of the product’s superior efficacy were are not supported and said that the claim that Zolpimist “induces sleep” in 10 minutes was misleading as no reference data existed to support the claim.

Purdue Pharma starts opioid settlement talks

Bloomberg has reported that Purdue Pharma is initiating settlement talks following the spate of lawsuits that claim its aggressive OxyContin opioid marketing led to a nationwide epidemic.

Together with Endo International, Janssen, Teva Pharma and Allergan, Purdue Pharma is named in an opioid marketing investigation by attorney generals from 39 states. Their focus was primarily on Purdue initially but investigators expanded their investigation in September.

According to Connecticut Attorney General, officials are open to settlement talks on the basis that companies talked up the benefits of opioid treatment for pain but downplayed the risks.

Sanofi testifies to Dengvaxia’s safety in Philippines

Sanofi has strongly defended the company’s dengue vaccine in the Philippines.

Meanwhile, new media reports raised questions about the genesis of the country’s immunization campaign, suggesting that the Department of Health’s effort went forward in the face of contrary advice from its own experts.

During a public Senate hearing, Sanofi’s Head of Asia Pacific, Thomas Triomphe said the company assures “each and every one of you that Dengvaxia is, and continues to be, a safe and efficacious vaccine.”

Triomphe told officials their recent decision to stop a national Dengvaxia immunization campaign will be a “regression” in the country’s approach to fighting dengue and a “disservice” to the public.

“We hope that knowing that other nations all over the world are not taking Dengvaxia off the shelf would prove that Sanofi Pasteur is telling you the truth that the vaccine is safe,” Triomphe said at the hearing and added that the vaccine is being used in 11 countries worldwide.

The Philippine authorities pulled the vaccinations shortly after Sanofi warned that Dengvaxia can cause infection to those who previously hadn’t had exposure to the virus. The Manilla authorities have also initiated a probe and there are talks of legal action plans legal action, according to the country’s Health Ministers.

Dengvazia was 20 years in development at a cost of $1.5 billion but it has yet to prove it’s commercvial despite big expectations and marketing approval granted in 19 countries.

October 2017

AbbVie hit with $140M fine in second AndroGel case

AbbVie has suffered a second AndroGel loss in court when earlier this month, afederal jury ordered AbbVie to pay more than $140 million to a plaintiff who suffered a heart attack and argued that the company’s aggressive marketing risked patient safety.

According to the plaintiff’s submission, he began taking AndroGel in 2010 and suffered a heart attack months later. Following a lengthy trial in Chicago, a jury sided with his arguments and awarded compensatory damages of $140,000 and punitive damages worth $140 million.

In his suit, the plaintiff said AbbVie gave no warning to patients and doctors that AndroGel could cause heart attacks and other serious side effects. He said the company’s drug promotions prompted men around the country to seek out the treatment, risking their health.

AbbVie said the company is disappointed with the verdict and that they intend to appeal

The verdict follows another major loss for AbbVie earlier this year. In July, a jury ordered the company to pay $150 million after hearing weeks of testimony.

Jurors in that case concluded that AbbVie wasn’t responsible for the plaintiff’s heart attack, nor was it negligent. But they did find that AbbVie misrepresented AndroGel. AbbVie pledged to appeal and said in its second quarter SEC filing that it “expects the punitive damage award will not stand.”

AmerisourceBergen to pay $260M over production of sterile cancer medicines

AmerisourceBergen has agreed to pay a $260 million federal misdemeanour fine and finally lay to rest a 5 year long Justice Department probe into its sales of of prefilled cancer drug syringes that were shipped from a facility that was never registered with the FDA.

The federal misdemeanour charge claimed that between 2001 and 2014, two of the the company’s Alabama-based subsidiaries, Oncology Supply Co. and Medical Initiatives, prepared millions of cancer drug syringes, including Aloxi and Anzemet as well as generics Neupogen and Procrit, at an FDA unapproved facility.

The probe dates to 2012, when the U.S. Attorney in the Eastern District of New York began looking into how the drug wholesaler was handling intercompany transfers involving its prefilled syringe program overseen by the now-defunct Medical Initiatives, the company’s oncology distribution centre and its group purchasing organization for oncologists.

This is the company’s second time in two months that it has settled federal probes around violating federal laws or standards. In August, it agreed to pay more than $13 million to settle federal allegations that its specialty pharmacy unit had pushed patients to get refills of Exjade in return for higher rebates from the Novartis. Novartis, for their part settled out of court with the Justice Department two years ago for $390 million.

Chinese drugmaker issued FDA warning over false test results

The FDA has issued Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert following an inspection that uncovered falsified test results and during which officials barred investigator access.

During the May inspection, Vianor Biotech management admitted to regulatory inspectors that they falsified analytical test results used to release many of its products to the U.S.

Additionally, the agency claimed the company reported a batch of one of its products was within specification in its certificate of analysis (CoA) despite lab analysis indicating the product was sub potent.

“When questioned about why the CoA reported passing results even though the batch actually failed, your quality unit manager stated, ‘I made a mistake,’” the FDA said in its letter sent to Vianor Biotech this week.

The inspection also found “rusted and corroded screws, fluid and debris and metallic mesh material on the product contact surfaces,” at the plant located in Linyi, China.

During the inspection, the agency said, company officials prevented an investigator from entering a room identified as a laboratory. Later, when allowed to enter the room, the investigator found no lab equipment in situ. The company said the laboratory was actually offsite, and that “it was not a convenient time” for the investigator to inspect those premises.

Talcum Powder Lawsuit Plaintiffs Claim J&J Knew of Talc Danger in 1970s

Plaintiffs pursuing talcum powder lawsuits in Missouri state court claim that newly unsealed documents show that Johnson & Johnson has known since the 1970s that its talc-based powders contained asbestos fibers, which could increase the risk of ovarian cancer in women who used the products daily.

According to Bloomberg, the documents were unsealed earlier this month in Missouri’s 22nd Circuit Court for St. Louis, where more than 1,000 plaintiffs accuse Johnson & Johnson of failing to warn consumers of the ovarian cancer risk allegedly associated with its Baby Powder and Shower-to-Shower products.

The unsealed documents include a May 1974 memo authored by an official at the Johnson & Johnson’s Windsor mine that recommended “the use of citric acid in the depression of chrysotile asbestos” from talc extracted from the site to “provide protection against what are currently considered to be materials presenting a severe health hazard and are potentially present in all talc ores in use at this time.”

In a 1973 report, a Johnson & Johnson official noted that sub-trace quantities of two types of asbestos had occasionally been identified in the company’s talcum powder, and that “these might be classified as asbestos fiber.”

Missouri is scheduled to convene its sixth talcum powder ovarian cancer trial on October 16, 2017. Four Missouri juries have already awarded talcum powder plaintiffs compensatory and punitive damages ranging from $55 million to $110 million. Only one jury has found for Johnson & Johnson.

More than 5,000 talcum powder lawsuits have been filed against Johnson & Johnson in courts nationwide. California’s first talcum powder trial concluded last month in Los Angeles Superior Court, with the jury awarding $417 million, including $340 million in punitive damages, to a woman with terminal ovarian cancer.

Aegerion to pay $35M to settle Juxtapid marketing breaches

Aegerion Pharmaceuticals will pay $35 million in fines for violating marketing rules in the promotion of its cholesterol lowering drug, Juxtapid

According to the US Department of Justice, Aegerion has agreed to a $7.2 million plea deal on criminal charges plus a $28 million civil settlement for two violations of the Food, Drug and Cosmetic Act, following allegations that it promoted Juxtapid outside of the drug’s FDA approval and broke risk-management and anti-kickback laws.

Juxtapid won its U.S. approval in 2012 to help lower cholesterol in patients with the rare condition, homozygous familial hypercholesterolemia. However, U.S. officials claim Aegerion sold the medication as a drug for high cholesterol generally.

Amongst the charges, prosecutors alleged that company sales representatives were briefed to advise doctors and patients that Juxtapid would “take patients out of harm’s way” and prevent “impending” heart attacks and strokes, despite the lack of data supporting the claims

It’s not the first time Aegerion has encountered trouble over its Juxtapid claims. In 2015, fired its CEO Marc Beer, for overhyping the produt’s efficacy, leading to an FDA warning letter and a Department of Justice subpoena over its marketing claimes. Aegerion merged with QLT last year to form rare disease drugmaker, Novelion. According to Novelion, the company generated $101 million in sales in 2016 with Juxtapid accounting for about two-thirds of total sales.

June 2017

Valium recall in Australia after tampering discovery

Roche has recalled all of its 5-mg Valium blister packs across Australia following a drug-tampering scare at a distribution centre in Sydney. The recall will result in a short-term nationwide supply of the product.

The recall followed evidence of a supply chain breach last week which Roche immediately to Australia’s Therapeutics Goods Administration. So far, there have been no reports of adverse reactions.

The investigation began after Roche discovered nine Valium blister pack sheets had been substituted with those of other drugs. Roche said the nine blister packs were from a batch of 30,000 packs per month that the company distributes to pharmacies nationwide. The company says it is confident that the tampering occurred after the Valium left its own warehouse in Australia.

J&J attempts to block Samsung’s biosim launch

Johnson & Johnson is taking legal proceedings against Samsung Bioepis on the basis that it is violating patents and refusing to participate in a patent dispute resolution process established for biosimilars.

The focus is on Remicade, one of Janssen Biotech’s leading products whose sales touched $5 billion in the U.S. last year. In an action filed in the U.S. District Court in New Jersey, it is claimed that Bioepis is violating three patents with its biosimilar version. The

J&J’s suit is asking the court to block the launch of the copy and compel Bioepis to follow the process. They are also seeking damages.

Bioepis however says it is “confident” that it is not infringing any of Janssen’s patents but J&J says Bioepis provided marketing notice too early and that by opting out of the patent dispute resolution process, it has “made it impossible” for Janssen to assess potential patent infringement.

Opioid Addiction: Another State sues drugmakers

Since 20117, drug overdoses have been the leading cause of accidental deaths in Ohio.

Now, State officials have lawsuit filed a lawsuit against Teva, Allergan, Johnson & Johnson, Purdue and Endo for alleged “fraudulent marketing practices” on opioid painkillers.

It claims the pharma companies, broke pharma marketing rules and “helped unleash” an opioid epidemic that has had “far-reaching financial, social, and deadly consequences” in the state. The companies did so, according to the suit, by marketing the medications pain treatment upsides without adequately highlighting the risks.

The State is seeking restitution and punitive damages, plus an order requiring the companies to stop the “unlawful promotion”.

Ohio has now joined rulers in Chicago, New York, Illinois and New Hampshire, who are pursuing opioid makers as addiction rates rise

China’s FDA to speed up trials process

China’s FDA is proposing to speed-up clinical trial approvals and remove restrictions placed on trial sites, with the aim of getting products to get to market more speedily.

Part of the initiative will see the agency lowering its certification system, which currently requires any facility wishing to conduct clinical trials to go through a lengthy certification process.

In addition, the agency is proposing a “no response = approval” mechanism thus cutting the lead time for researchers commencing new studies.

As part of a series outlined on May 11, the China FDA plans to change its clinical trial approval system to one similar to the U.S. FDA’s Investigative New Drug (IND) process.

Under current rules, a company must wait for the CFDA’s official go-ahead before beginning a clinical trial. The new proposal, however, would give the agency 60 working days to either reject or query an application. In the absence of both by day 60, the application would be assumed to be approved.

The agency is also encouraging private and public companies and hospitals companies to establish dedicated trial sites, rather than relying on healthcare treatment facilities at public hospitals.

In addition, foreign companies and research authorities will be allowed to conduct Phase 1 trials in China.

E.U. States jostle to lure EMA HQ

Up to 20 individual E.U. countries are josstling for poll position to provide a post-Brexit H.Q. for the European Medical Agency. Although the E.U. decision makers have not yet announced any official criteria for the move, most E.U. countries are not holding back in making their case to lure the EMA, its 900 or so employees and the local economic benefits which re-homing the EMA would provide.

Ireland is playing on the EMA’s concern over its loss of staff expertise by suggesting how a move to Dublin would greatly assist staff retention, by enabling many of its current employees to commute from its current London base where the EMA has resided for the past 20 years.

Denmark utilising the sector expertise of former Novo Nordisk CEO Lars Rebien Sørensen who is acting as a special envoy to promote the case for Copenhagen.

Spain is eager to see the authority move to Barcelona by promoting Barcelona’s infrastructure, attractive lifestyle and culture.

Other aspirants are believed to be Germany, Italy, Romania, Czech Republic, Belgium, Croatia and Malta.

The new location will be decided by the EU’s heads of state, whose next European Council Meeting is scheduled for June 22-23. Europe’s drugmakers and the EMA’s Executive Director Guido Rasi are pushing for a decision to be made then.

Teva to shut plant in Hungary

Teva is abandoning its sterile injectables plant in Godollo, Hungary. The unit halted production last year after the FDA found manufacturing failings of “potentially significant sterility assurance”. The closure will result in the loss of hundreds of jobs and the plant will sell or close next year.

Teva confirmed local media reports this month about its plans to close the facility on the fringe of Budapest but emphasised that its overall commitment in Hungary remains via its plants in Debrecen and Sajóbábony and its 2,000 employees.

The reason given for the closure of its injectables plant was to “align production capacity with market and patient demand globally.”

The announcement comes on the heels of media reports in March that the company was planning cut up to 6,000 jobs globally.  At the time, the company confirmed plans to reduce costs, but said Teva did not have a headcount target.

E.U. to investigate Aspen’s cancer drug pricing

Aspen Pharmacare is under investigation by the EU’s competition authorities over its pricing of five cancer medicines

The E.U. Commission said it was looking into concerns that the South African pharma company had “engaged in excessive pricing” for five drugs – with reports that some drugs had their prices increases by several hundred per cent – and had “abused a dominant position” in the market.

The five generic medicines – chlorambucil, melphalan, mercaptopurine, tioguanine and busulfan – are used for treating a broad range of cancers, and the Commission is concerned that Aspen may have used the tactic of withdrawing or threatening to withdraw them from sale in some EU member states, leading to shortages.

This is the first time that the EU authorities have investigated a drugmaker for unjustified price increases, although in the US the Securities & Exchange Commission (SEC) has started an investigation into possible price-fixing among generic medicine drugs in the wake of some very high-profile pricing scandals.

Earlier this year, UK researchers told delegates at the European Cancer Congress (ECCO) in Amsterdam that the prices of 14 cancer drugs have increased by between 100% and nearly 1,000% over the past five years in the UK – adding £380m to the NHS bill.

Though Aspen’s price rises were not acted on in the UK, in Italy the drugmaker was fined after threatening the Agenzia Italiana del Farmaco (AIFA) that it would stop supplying drugs if they were unable to introduce big hikes.

The EC said its investigation will cover all countries in the European Economic Area except Italy, which the company €5m last September for “unfair prices with increases up to 1,500% for life-saving and irreplaceable drugs”.

In April, the UK’s Department of Health introduced the Health Services Medical Supplies Costs Bill in order to be able to regulate prices in the future.

Last December, Pfizer was fined £84 million by the UK’s Competitions and Markets Authority (CMA) for conspiring with Flynn Pharma to raise the price of epilepsy drug phenytoin and CMA has since launched an investigation into the pricing of Actavis’ hydrocortisone tablets.

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Medtronic aims for 4% growth and announces an FDA approval

Medical device company, Medtronic is targeting a 4% annual increase in revenue through investments in higher-growth technology markets, according its plans outlined at its biennial investor briefing in New York in June.

In order to increase savings in its global operations, the company plans to continue consolidating its manufacturing footprint from a peak of 92 to closer to 55 inover the next few years. The company also plans to reduce its supply chain base by about 50%.

At present, Medtronic maintains about 70 sites but will lean towards contract manufacturing where possible.

The intended financial aims are to grow adjusted earnings per share by 8%, expand its underlying operating margin by 40 to 50 basis points, return at least half of its free cash flow to shareholders and continued growth in emerging markets.

Separately in the month, the Irish headquatered company announced that the U.S. FDA has approved its state-of-the art Deep Brain Stimulation (DBS) Clinician Programmer and ActivaProgramming Application. The ActivaProgramming Application was designed with the input of over a hundred clinicians globally and is managed on the Samsung Galaxy Tab S2 tablet interface to enhance the clinical programming experience, streamline workflows and provide actionable information to support neurologists and neurosurgeons in their treatment of patients with neurological diseases such as Parkinson’s and Dystonia.

Headspace targets 2020 FDA approval for meditation app

Headspace is aiming for FDA capproval for a prescription based meditation app by 2020.

The mindfulness and meditation specialists have formed a digital health subsidiary to test the app in randomised controlled trials, clinical validation and regulatory processing.

Founded in the U.K. in 2010, Headspace is a key player in consumer-focused, digitally delivered, guided meditation.

With efficacy being its key hurdle on the path to FDA approval, Headspace is gathering efficacy data through studies and analysis which is says are are rigorous, multi-site and high-calibre.

Amazon eyes health-tech

Amazon is understood to have created a research division with a view to extending its reach into healthcare technology, cancer research and medical records.

According CNBC reports, the company’s Grand Challenge research group has been working with Fred Hutchinson Cancer Research Center to develop machine learning tools for oncology.

A Fred Hutch spokesperson told CNBC that it has several early-stage projects underway with tech pioneers, including Amazon, Microsoft and Tableau Software, and that hopes to preview them later in the year.

According to CNBC, Grand Challenge sits within the Amazon Web Services divison and team members are chosen through its annual “Think Big” competition, involving presentations of the next big ideas.

Amazon has already explored into the pharmacy and drug distribution spaces. Some industry analysts believe the company could dive in as early as next year.

Earlier this year, Amazon hired FDA’s former chief informatics officer, Taha Kass-Hout, M.D., who was the agency’s inaugural CIO who led the FDA’s DNA sequencing data programme – PrecisionFDA.

Medtech Highlights: Q1 2018

NeuroVision looks to snare $15M in series C financing round

Diagnostics player NeuroVision is looking to capture $15 million in a series C round of financing with an initial close of $11.2 million.

Funds from the financing will be used to support validation and gain regulatory approval for its retinal imaging technology designed for the early detection of Alzheimer’s disease.

The financing round is being led by Wildcat Management with participation from Johnson & Johnson Innovation, Nikon-SBI Innovation Fund, Whittier Ventures and VSP Global.

NeuroVision’s test identifies build-up of amyloid-beta protein in the retina, which has similar characteristics to the brain. Studies have shown that amyloid-beta plaques that build up in Alzheimer’s patients’ brains also accumulate in the retina. The hope is that monitoring the retina could help doctors spot Alzheimer’s earlier and guide treatment.

Datavant Acquires Universal Patient Key and Closes $40M Financing Round

Datavant has acquired Universal Patient Key (UPK), a leading provider of HIPAA-compliant de-identification services for healthcare data.

UPK has created a suite of software products that de-identify structured and unstructured health data through HIPAA-compliant methodologies.

By using UPK’s industry-leading software and services, healthcare stakeholders can securely share patient-level healthcare data while minimizing the risk of unauthorized access and patient re-identification. The services enable the shared use of longitudinal, real-world evidence to further medical research, improve health outcomes, and reduce the cost of delivering care, while at the same time protecting the anonymity of individual patients.

Check-Cap Receives CE Mark Approval for C-Scan®

Check-Cap Ltd., a clinical-stage medical diagnostics company engaged in the development of C-Scan®, an ingestible capsule for preparation-free, colorectal cancer screening, announced it has received CE Mark approval for the C-Scan system.

The C-Scan system offers an alternative to current colon cancer screening methods that require laxative preparation and invasive endoscopic procedures. This novel platform consists of a fully autonomous system that utilizes an ingestible, ultra-low dose X-ray capsule combined with a state of the art wireless tracking system, enabling generation of structural information on the lumen of the colon.

This information is used to create 2D and 3D maps of the colon, allowing physicians to identify pre-cancerous polyps and other abnormalities.

C-Scan is designed to improve the patient experience and increase the number of adults screened by eliminating procedural requirements frequently cited as barriers to adherence to screening guidelines such as bowel preparation, fasting, and sedation.

Tandem Diabetes Care Announces Closing of $69 Million Underwritten Public Offering of Common Stock

Tandem Diabetes Care, a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, has announced the closing of its previously announced underwritten public offering of 30 million shares of common stock at a price to the public of $2.00 per share.

In addition, the underwriters fully exercised an option to purchase 4.5 million additional shares of common stock at the public offering price. All of the shares in the offering were offered by Tandem, with gross proceeds to Tandem of $69 million from the offering of an aggregate of 34.5 million shares.

HeartFlow Completes Series E Financing, Securing $240 Million

HeartFlow, Inc. has announced the closing of its Series E financing, securing $240 million. The company will use the proceeds from this financing to ramp up commercial expansion of the HeartFlow® FFRct Analysis, continued technology innovation and additional clinical studies.

The HeartFlow Analysis is a non-invasive technology that creates a personalized 3D model of the heart to help clinicians diagnose and treat patients with suspected heart disease.

The financing includes investments from Wellington Management, Baillie Gifford & Company and existing investors.

Medtech News

Q4 2017 Highlights

TransEnterix announces first U.S.purchase agreement for Senhance™ Surgical System

TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery has  announced that Florida Hospital has entered into an agreement to purchase the Company’s Senhance™ Surgical Robotic System.

The Florida Hospital Orlando campus will be home to the first commercial unit of the Senhance Surgical System to be installed in the United States.

The recently FDA-cleared Senhance Surgical System represents an innovative technology designed to assist surgeons in performing minimally invasive surgery. The system features multiple robotic arms that are controlled by a surgeon seated comfortably at a console. The surgeon controls small surgical instruments with robotic precision while at the same time moving a small scope that tracks the eye movement of the surgeon.

The Senhance is the first surgical robotic system to offer the security of haptic force feedback that allows surgeons to feel the forces the instruments generate when handling delicate tissue. The Senhance represents a new era of digital laparoscopy designed to support responsible economics for the hospital, patient and today’s value-based healthcare system.

Medtronic acquires gastro diagnostics Crospon in $45m deal

Medtronic has acquired gastrointestinal disorder diagnostic company Crospon. Medtronic has not confirmed the exact value of the deal but London’s Times newspaper has reported it could be worth up to $45 million (EU €38 million).

West of Ireland based Crospon, produces endoscopic diagnostics, including its FDA approved Endoflip system, which includes the company’s Flip topography module designed to allow for the assessment of patient motility disorders during endoscopy.

The system includes imaging software that displays esophageal contractility patterns in real time on a touchscreen display and allows for the investigation of conditions including achalasia, GEJ outflow obstruction and other major or minor peristalsis disorders during endoscopy.

FDA approves First Medical Device Accessory for Apple Watch

AliveCor has announced FDA clearance of KardiaBand in the U.S., allowing Apple Watch users to discreetly capture their EKG anytime, anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia.

KardiaBand is the first FDA-cleared medical device accessory for Apple Watch. It can record an EKG in 30 seconds with just a touch of its integrated sensor. Results from the Kardia App are displayed on the face of Apple Watch.

KardiaBand retails for $199 plus an annual subscription fee of $99 a year.

Hancock Jaffe Laboratories sets terms for $13 million IPO

Hancock Jaffe Laboratories, which is developing bioprosthetic devices for cardiovascular surgeries, announced terms for its IPO. The Irvine based company plans to raise $13 million by offering 1.88 million shares at a price range of $6 to $8. At the midpoint of the proposed range, Hancock Jaffe Laboratories would have a market value of $62 million.

It plans to list on the Nasdaq. WallachBeth Capital and Network 1 Financial Securities are working joint on the deal. IPO timing has not been disclosed.

Virtual Incision Announces $18 Million Series B Funding for Miniaturized Surgical Robots

Virtual Incision Corporation has has raised $18 million in Series B funding.

The round was co-led by new investor Sinopharm Capital, the private equity fund initiated by Sinopharm Group, China’s largest healthcare company, and existing investor Bluestem Capital, with participation from PrairieGold Venture Partners and others.

This financing will support the company’s premarket notification submission to the U.S. FDA for its next-generation miniaturized robotically assisted surgical device (RASD). The Virtual Incision RASD is designed to enable physicians to perform less-invasive general surgery abdominal procedures that today are usually performed via large, open incisions, including multi-quadrant surgeries such as colon resection.

While similar to other RASDs with regard to intended use, Virtual Incision’s technology takes a new and unique approach to robotically assisted surgery by using a small, dexterous and self-contained surgical robot that does not require a dedicated operating room or specialized infrastructure.

The company’s key focus is on the under-served 80% of the market where smaller and simpler solutions are in demand.

Genesis Innovation Group launches $10m Cultivate (MD) medtech venture fund

Mhicigan based Genesis Innovation Group has created a Cultivate(MD) Capital Fund, which aims to manage $10 million to invest in early stage healthcare companies with a focus on medical device and orthopedic technologies.

The company says it expects the fund to be fully operational and seeking companies to invest in by early 2018. The fund will focus on investing in early stage medtech companies with “demonstrated evidence of effectiveness” with goals of reducting the cost of healthcare while improving outcomes for patients

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