Legal & IP
The payout will bring GSK closer to resolving lawsuits which have occupied it for years – though investors are now likely to focus on new product growth concerns at the UK firm.
The US International Trade Commission looks set to ban the importation of Ascletis's THRβ agonist into the US for use in clinical trials due to an initial legal determination on potential infringement of trade secrets related to Viking's same-class candidate VK2809.
The charges stemmed from allegations of manipulation of Phase II data for the Alzheimer’s disease drug simufilam.
"Illegal" copies of Pfizer’s Lorbriqua and Eli Lilly’s Verzenio have been seen making their way to India allegedly via manufacturers in Bangladesh. The US multinationals are engaged in a legal battle in India to tackle the ‘infringement’ amid wider concerns around inadequate regulatory oversight.
MSN Laboratories will be unable to move forward – for now – with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US after the originator won a stay on the firm’s ANDA pending appeal from the US Court of Appeals for the District of Columbia Circuit.
The UK group remains confident that the scale of the US opioid epidemic, driven by misuse of fentanyl, still represents a considerable opportunity but investors have reacted nervously to lower revenues coming from Sublocade.
The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits.
In this week's podcast edition of Five Must-Know Things: Biogen’s immunology acquisition; AstraZeneca looks to cement respiratory lead; why US FTC is tough on pharma; the US election’s impact on pharma; and how new AI tools are impacting medical affairs.
As the proposed US BIOSECURE Act heads to a full House Oversight Committee vote, Scrip's China-based editors Brian Yang and Dexter Yan, together and guest Derrick Gingery from the Pink Sheet, discuss the implications and potential outcomes for the biopharma sector and factors behind the "biotech decoupling" trend. Dexter also shares insights from his recent coverage of antibody-drug conjugate R&D updates by Chinese companies.
Apparently months after his actual detention, news has finally surfaced that a key researcher behind China's rapid development of a homegrown COVID-19 vaccine is said to have "severely violated" Communist Party rules and regulations and is the subject of a probe for possible corruption.
More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding off a local drug maker in the Evrysdi patent infringement case.
The European parliament has voted for legislation it says will lead to fairer, more accessible healthcare. The continent's drugmakers are still not wholly convinced.
The embattled US biotech has gone into Chapter 11 and linked up with 'stalking horse' bidder Merz which has offered $185m to get hold of Ampyra for multiple sclerosis and Parkinson’s therapy Inbrija.
Eisai/Biogen’s Alzheimer’s drug has fallen foul of a recent court ruling over the handling of the European Medicines Agency’s experts' competing interests.
Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.
CEO Bill Anderson says that while the troubled Leverkusen-headquartered group operates three healthy businesses, it has been "badly broken in four places.”
The German biotech has distanced itself from recently resigned head Werner Lanthaler who appears to have violated the rules regarding the buying and selling of stock.
As the president’s reelection campaign themes take shape, the administration is preparing to leverage NIH patents in ways it had previously eschewed. As with the merger oversight effort, though, the germs of the plans began earlier in Biden’s tenure.
Drug manufacturers will have to participate in the Medicare drug price negotiation process for the foreseeable future. Judge Newman's finding that participation in Medicare is voluntary could defeat constitutional challenges to the program and have an impact on other cases.
A Chinese court decision sheds light on how Chinese major Hengrui Medicine is seeking to reduce or avoid potential losses worth up to $27m following regulatory setbacks with the tubulin inhibitor plinabulin, in-licensed from BeyondSpring in 2021.