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Regulatory uncertainty in the wake of Brexit could leave Britain's multi-billion-pound medical technology industry out in the cold, with separate regulatory systems threatening exports and jobs…That is the warning from the Institution of Mechanical Engineers…which…became the latest group to highlight the problem of regulatory uncertainty once Britain leaves the European Union…industries from aerospace to pharmaceuticals and chemicals fear Brexit may create a regulatory vacuum…the IME called on the British government to harmonize its post-Brexit rules with EU regulations on medical devices - a category covering everything from heart stents to walking aids - or risk losing billions of pounds in exports…Leaving the EU without the UK medical technology industry suffering considerable long-term damage, particularly for small businesses, will be a huge challenge…it is vital that the UK is able to maintain continuity with the EU CE certification processes, and enable UK manufacturers to export medical devices into the 100 billion euros European med tech market…

The specialty drugs market is seeing increased competition and important advances in cancer and orphan drug development, including specialty generics and biosimilars...Following December’s FDA approvals of the intravenous biosimilar Lartuvo (olaratumab) for soft tissue sarcomas and the oral ovarian cancer biosimilar Rubraca (rucaparib), biosimilar and other specialty drug approvals are expected to hasten in 2017... Last year we saw a dip in...approvals but this year we are going to rebound with about 30 pending approvals...With 73 patent expirations for biologic agents by 2021, biosimilars will begin to emerge as a larger market presence in the next several years...New FDA biosimilars approvals over the next five years—including anticipated biosimilar approvals for the anti-cancer biologic agents Avastin (bevacizumab) and Herceptin (trastuzumab)—could represent a $46.2 billion market...Biologics are really acting more like competing brands, coming in at perhaps a 15% discount" compared to brand-name biologics...

• Pending approvals/patent expirations
• Recently approved specialty medications
• Specialty drug pipeline

The US FDA and the European Union took an important step forward this week in pharmaceutical manufacturer inspection collaboration, completing an exchange of letters that will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders...the letters, which will amend the Pharmaceutical Annex to the US-EU Mutual Recognition Agreement, will enable the FDA and EU to "avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk...The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs…

When it switched offices in London not long ago, the European Medicines Agency signed a 25-year lease on a shiny new building in the east of the city...Just two years later, the organization is preparing to relocate again, but this time its likely move has sent tremors through Britain’s pharmaceutical industry and raised fears over public safety...the European Medicines Agency...will almost certainly have to leave Britain, just one of the many unanticipated consequences of the vote that is forcing the country to unscramble 40 years of European integration...cities...are scrambling to lure its team of experts, who license drugs and monitor their use for safety...Most worrisome is an internal assessment suggesting that relocating the agency might mean losing up to half its personnel...With a full workload of applications in the pipeline, the organization is already close to the breaking point…If it loses more than 15 percent of its experts….the agency will probably not be able to maintain current schedules for licensing new drugs and monitoring existing ones...

China’s FDA proposed changes to its foreign drug registration regulation in mid-March, aiming at speeding up approvals. The changes have provoked anticipation for growth among Western drugmakers, particularly around two provisions having to do with drug trials…

• The CFDA would no longer require that a drug be tested through phase 1 elsewhere before being tested in humans in China, and
• ...foreign drugmakers can use data from international multicenter trials that have been conducted in China to directly file for marketing approval.

...the change would attract greater investment from drugmakers and dramatically reduce the time to introduce blockbuster treatments...the new regulation "allows the imported innovative drug to move forward more naturally in China and not be required to be tied to international[-only] processes…I think [the Chinese government] has removed some significant obstacles and at the same time wishes to retain flexibility...what is clear is China’s goal to take the lead in pharmaceutical innovation, to become a launch pad of new meds...it’s about a national pride that doesn’t want to forever be left out in a global innovation discourse..."There is less the need to protect domestic industry than to play a leading role,"…Western companies will remain an "ever-present competitive force," and gradually opening up that competition will force domestic firms to up their game, to stand on their own feet and not rely on subsidies, and gradually eliminate those who cannot keep up…

China's FDA published a slate of suggested amendments to its foreign drug registration rules...which could dramatically revamp the country’s pharmaceutical market landscape by eliminating hurdles that slow approvals of Western drugs. Pharma companies quickly hailed the changes...the new rules would allow foreign drugmakers to file for a new drug approval using data from international, multicenter trials, so long as those trials include China as a study site. Translation: No China-specific trial applications would be required for those foreign drugs...When finalized and implemented, these policies will encourage biopharmaceutical innovation and accelerate the approval process for new medicines...They will also pave the way for China's integration into the system for multiregional clinical trials that undergirds global drug development...

Hoping to speed up future regulatory review for its drug candidates, Gilead has agreed to buy a priority review voucher from Sarepta Therapeutics for $125 million...Sarepta had obtained the voucher — a transferrable credit designed to speed review by the Food and Drug Administration by four months — for winning approval of its disease-modifying treatment for Duchenne muscular dystrophy last year...Sale of the voucher, albeit for a lower price than some had expected, will bolster Sarepta's cash position and help fund clinical development of Sarepta's pipeline and manufacturing scale-up…For Gilead, the voucher could be used to speed review for one of its several late-stage candidates. The $125 million is a relative bargain as well, compared to both the recent prices paid by Sanofi and AbbVie as well as to Gilead's large cash hoard.

President Donald Trump’s pick to head the U.S. Food and Drug Administration is among the most vigorous advocates of lowering drug costs by approving cheap generics faster, an initiative aimed directly at the profit centers of major companies...Scott Gottlieb, a former FDA deputy commissioner, would make streamlining approvals his top priority...He’s particularly focused on complex medications that combine old drugs with newer delivery devices, as well as those with unusually complicated formulations...The administration could make the changes without Congress passing a law...But it also risks angering companies that have considerable legal firepower to defend their money-makers...Getting more generics to market faster could save Americans billions of dollars a year...Absent a new law, the FDA could do much to speed approval of generics. It could devise broad guidelines for copies. And the agency could become swifter in approving drug-device combos, finding ways to allow slight differences so long as they wouldn’t confuse patients...

• President’s Pledge
• Complicated Cures
• Pricey Pens
• EpiPen Dispute

Industry groups are taking aim at a rule created by the Food and Drug Administration that could restrict drugmakers' truthful and non-misleading promotion of its drugs — commonly referred to as off-label promotion — by expanding the evidence the agency can use to assert that a drug has been misbranded...For example, under the new rule — pertaining to the FDA's definition of intended use — if a manufacturer discovers that one of its products is being used off-label and, as a result, adjusts its supply and scales its manufacturing to meet higher demand for those off-label uses, the FDA could use the company's internal documents describing that intention to scale up as evidence of a new intended use...The agency expanded the definition of intended use to now include “totality of evidence.”...The new intended use rule exposes manufacturers to a significant risk of liability for conduct that is entirely lawful and beneficial to the public health...

With hundreds of open positions and a slate of new initiatives to execute on at the FDA, President Donald Trump picked a particularly inconvenient time to declare a hiring freeze for the federal government...No one really knows how this is going to play out, but the speculation is rampant that the FDA will be forced to cut loose from its review timelines, which could have a big impact on a wide range of biopharma companies...the agency is expected to get a record 1600 ANDAs this year. Trump’s freeze could slow reviews on generics to a glacial pace, which in turn would interfere with the introduction of new discounted drugs that could go a long way to removing pressure on new drug prices...The only guarantee Trump can offer now is a rising level of uncertainty over the administration’s plans for the FDA. And that could take months to clarify during a particularly critical year for the biopharma industry...