Legal
Refine Search
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
Generics
US specialty drugmaker Depomed has entered into settlement agreements with two of the three defendants involved in Depomed's ongoing patent infringement litigation against filers of Abbreviated New Drug Applications seeking approval to market generic versions of Depomed's Gralise (gabapentin) 300mg and 600mg tablets. 15 April 2014
Pharmaceutical
UK pharma major GlaxoSmithKline is facing allegations of bribing doctors in Poland, according to the UK’s public broadcaster the BBC, which will air the claims in a program tonight. 14 April 2014
Generics
US generic major Mylan today confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals, part of Endo Health Solutions, and Mylan on patent litigation in connection with Mylan's filing of an Abbreviated New Drug Application) for frovatriptan succinate, a generic version of Endo’s Frova, which is used to treat acute migraine headaches in adults. 11 April 2014
Generics
The UK’s High Court has ruled that two patents on Swiss drug major Roche’s breast cancer drug Herceptin (trastuzumab) were invalid, allowing global speciality pharma company Hospira to launch a generic version. 11 April 2014
Pharmaceutical
Following similar recent action by the equivalent Italian body, the French competition authority is launching an investigation into possible anti-competitive practices by Swiss pharma majors Roche and Novartis relating to their ophthalmic drug Lucentis (ranibizumab). 10 April 2014
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical has been ordered to pay $6 billion in punitive damages by a US court over claims that it hid cancer risks associated with type 2 diabetes drug Actos (pioglitazone hydrochloride). 8 April 2014
Pharmaceutical
The European Medicines Agency confirms that US drugmaker AbbVie has withdrawn both its court cases brought against the Agency concerning access to clinical-trial data. 4 April 2014
Pharmaceutical
US pharma major Eli Lilly says that the US District Court for the Southern District of Indiana has ruled in the company's favor regarding the vitamin dosage regimen patent for its cancer drug Alimta (pemetrexed for injection). 1 April 2014
Pharmaceutical
Israel’s Teva Pharmaceutical Industries, the world largest generic drugmaker, says that the US Supreme Court has granted the company’s Copaxone (glatiramer acetate) certiorari petition. Teva’s shares rose 6.9% to $52.84 in New York trading yesterday. 1 April 2014
Generics
US generics major Actavis says that the US Court of Appeals for the Federal Circuit has reversed a lower court ruling that Actavis' generic version of Ireland-headquartered Shire's Lialda (mesalamine extended-release tablets) infringes US Patent No 6773,720 (the '720 Patent). 31 March 2014
Generics
US generics major Mylan reveals that, after a trial in the US District Court for the District of New Jersey, a jury returned a verdict in favor of Mylan in its breach of contract law suit against UK pharma giant GlaxoSmithKline relating to paroxetine hydrochloride extended-release tablets, the latter’s once blockbuster antidepressant Paxil. 27 March 2014
Biotechnology
Earlier this week in the USA, legislation was introduced allowing new sponsors to gain intellectual property protection for already-approved biologic drugs that gain approval for new indications by Senator Richard Blumenthal (Democrat, Connecticut) and Representatives Joaquin Castro Joaquin Castro (Dem, Texas) and Randy Forbes (Republican, Virginia). 26 March 2014
Generics
US generics major Mylan says the US District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist (formoterol fumarate) Inhalation Solution. 25 March 2014
Generics
Generic drugs major Actavis has entered into an agreement with Noven Pharmaceuticals, a subsidiary of Japan’s Hisamitsu Pharmaceutical, to settle all outstanding patent litigation related to Actavis' generic version of Daytrana (methylphenidate transdermal system), a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder 20 March 2014
Pharmaceutical
The European Medicines Agency has published its work program for 2014 with a focus on legislative developments. 19 March 2014
Generics
US pharma giant Pfizer is taking legal action against Indian drugmaker Torrent Pharmaceuticals to stop it selling a generic version of erectile-dysfunction drug Viagra (sildenafil) while the patent is still active. 19 March 2014
Biotechnology
Switzerland-based Actelion says that the California Supreme Court has denied the firm’ petition for review of the Court of Appeal's decision affirming the final judgment entered against Actelion in November 2011 in Asahi Kasei Pharma Corp v Actelion Ltd, et al. 14 March 2014
Pharmaceutical
Delegates at The Economist’s Pharma Summit in London yesterday were greeted by AIDS activists picketing the entrance as they arrived. 14 March 2014
Biotechnology
US drugmaker Idenix Pharmaceuticals says it has filed patent infringement law suits against biotech firm Gilead Sciences and/or certain of its subsidiaries in each of three countries - France, Germany and the UK. 14 March 2014
Pharmaceutical
US pharma behemoth Pfizer confirmed today that the US District Court for the Eastern District of Virginia granted summary judgment invalidating the reissue patent (US Patent No RE44,048), covering methods of treating osteoarthritis and other approved conditions with celecoxib. 13 March 2014
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze