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Pharmaceutical
To ensure continued investment in the development of tomorrow’s breakthrough treatments and cures, innovators must be able to protect and enforce patents and other intellectual property, says Jay Taylor of Pharmaceutical and Research Manufacturers of America (PhRMA). 25 April 2017
Generics
French pharma major Sanofi has added to Mylan’s woes over the Netherlands-incorporated drugmaker’s EpiPen (epinephrine) Auto-Injector device. 25 April 2017
Biotechnology
Immunex has initiated legal proceedings against French pharma major Sanofi (Euronext: SAN) and US biotech Regeneron Pharmaceuticals (Nasdaq: REGN). 21 April 2017
Pharmaceutical
The French National Agency for the Safety of Medicines (ANSM) has released a study showing up to 4,100 children were born with a severe congenital disorder after being exposed in the womb to valproate, a Sanofi product. 21 April 2017
Generics
The US Food and Drug Administration (FDA) has warned Netherlands incorporated Mylan that unless it addresses manufacturing violations at its facility in Maharashtra, India, then the agency could withhold approval of any new applications or supplements listing the firm as a drug manufacturer. 12 April 2017
Pharmaceutical
Nexavar (sorafenib tosylate), a crucial drug for kidney and liver cancer for which German pharma major Bayer was granted a patent on March 3, 2008, has come under fire in India, whereby a landmark court ruling is set to define the contours of Bolar exception provisions in the Indian Patents Act, reports The Pharma Letter’s India correspondent. 10 April 2017
Generics
US Representatives David McKinley (Republican: West Virginia-1) and Peter Welch (Democrat: Vermont) last week introduced the Fair Access for Safe and Timely (FAST) Generics Act. 8 April 2017
Generics
On April 6, 2017, the British Court of Appeal upheld Flynn Pharma’s right to stop the parallel importation into the UK of Pfizer’s Epanutin (phenytoin sodium) anti-epileptic drug for resale as Phenytoin Sodium Flynn. 7 April 2017
Generics
Jordanian drugmaker Hikma Pharmaceuticals has reached a settlement with Jazz Pharmaceuticals that resolves patent litigation related to the Ireland-based company’s Xyrem (sodium oxybate) oral solution, 500mg/mL product. 6 April 2017
Generics
Mallinckrodt has reached an agreement in principle with the US Drug Enforcement Administration (DEA) and the US Attorneys' Offices (USAOs) for the Eastern District of Michigan and the Northern District of New York regarding controlled substances. 4 April 2017
Pharmaceutical
Sanofi Pasteur has agreed to pay $19,868,194 to resolve claims that it incorrectly calculated drug prices and thereby overcharged the US Department of Veterans Affairs (VA) for drugs under two contracts between 2002 and 2011, the Department of Justice revealed yesterday. 4 April 2017
Biotechnology
A US patent court has ruled that Biogen's patents on its blockbuster multiple sclerosis drug Tecfidera (dimethyl fumarate) are valid. 3 April 2017
Biotechnology
The international medical humanitarian organization Médecins Sans Frontières (MSF) has filed a patent challenge on the hepatitis C virus (HCV) drug sofosbuvir with the European Patent Office (EPO) in an effort to increase access to affordable treatment for patients globally. 28 March 2017
Biosimilars
Daniel Gallagher – who from November 2011 to October 2015 was Commissioner of the US Securities and Exchange Commission (SEC) – has joined Netherlands-incorporated drugmaker Mylan as the company’s chief legal officer. 28 March 2017
Generics
Chugai Pharmaceutical has announced its final victory in a lawsuit in which it sought injunction against generic drug manufacturers based on infringement of the process patent (Patent No 3310301 on Oxarol. 27 March 2017
Biosimilars
Key authorities, eminent lawyers and industry leaders this week discussed in London the proposals put forward by the European Commission to stimulate jobs and growth in the pharmaceutical sector in Europe at the Medicines for Europe 13th Legal Affairs Conference. 23 March 2017
Pharmaceutical
Having not only lost out on damages worth C$500 million ($374 million), US pharma major Eli Lilly faces a bill of around C$5 million due to a lost legal fight with the Canadian government. 22 March 2017
Pharmaceutical
A quartet of companies have been named and shamed for breaching the Association of the British Pharmaceutical Industry’s (ABPI) code of practice. 14 March 2017
Biotechnology
A Delaware judge has ordered a delay in the closing of a $2 billion drug licensing deal between US biotech companies Immunomedics and Seattle Genetics. 10 March 2017
Biosimilars
When a UK High Court judge handed down a judgement to clear the route to market for biosimilar versions of the world’s biggest-selling prescription drug on Friday, the impact on the three companies involved was always going to be significant. 8 March 2017
Biotechnology
India’s Sun Pharma has been blocked in its efforts to launch its JAK inhibitor Leqselvi (deuruxolitinib) in the USA. 6 November 2024
article
The European Union's antitrust enforcer hit Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) with a 463 million-euro ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to entering the market. 31 October 2024
Biotechnology
UK pharma major GSK has sued USA-based Moderna this week, accusing the latter of violating patents protecting GSK’s COVID-19 vaccine. 16 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Pharmaceutical
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Pharmaceutical
Cardiopulmonary diseases specialist Liquidia Corporation closed Monday’s trading 11% higher following a favorable court ruling. 8 October 2024
Generics
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
Pharmaceutical
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Biotechnology
Bristol Myers Squibb has scored a major legal victory as a judge in New York dismissed a $6.4 billion lawsuit related to its acquisition of cancer company Celgene. 5 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
Pharmaceutical
Texas-based Cassava Sciences was trading 13% lower in Friday’s pre-market trading. 27 September 2024
Pharmaceutical
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Pharmaceutical
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
Pharmaceutical
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
Generics
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
Generics
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
Generics
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
Biosimilars
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Pharmaceutical
Ireland-headquartered Avadel Pharmaceuticals has updated on litigation with USA-based Jazz Pharmaceuticals. 29 August 2024
Pharmaceutical
Liquidia Corporation announced Thursday that it has filed litigation in the US District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the US Food and Drug Administration (FDA) to grant three-year new clinical investigation (NCI) exclusivity to Tyvaso (treprostinil) DPI.9.6. 23 August 2024
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