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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
Pharmaceutical
The Russian Parliament (State Duma) has started the design of legislation that will allow Russia to produce patented imported drugs of those global producers who refuse further drug imports to Russia, due to sanctions or other unfounded circumstances, according to an official representative of the Duma, reports The Pharma Letter’s local correspondent. 5 August 2015
Biotechnology
Ireland-based Horizon Pharma has challenged Depomed’s attempt to shield itself from a $1.75 billion hostile takeover bid. 4 August 2015
Generics
Government authorities in Romania are investigating charges of corruption against domestic units of nearly a dozen big pharma companies including Roche (SIX: ROG), GlaxoSmithKline, Pfizer and Novartis, according to reports. 3 August 2015
Pharmaceutical
In a US federal court victory for Indian drugmaker Ranbaxy, in a suit that was the first test of what antitrust limits may be placed on reverse payment deals among drugmakers. 2 August 2015
Generics
Mylan says it has received regulatory clearance from the European Commission under the European Union Merger Regulation (EUMR) for its proposed, unsolicited acquisition of Ireland-based Perrigo. 29 July 2015
Pharmaceutical
Ansun BioPharma, a San Diego-based biotech company formerly known as NexBio, says that an investigation by the US Attorney's Office over the misconduct of its former chief executive and chief financial officer has been dismissed. 27 July 2015
Biotechnology
Neuralstem said yesterday that the US District Court for the District of Maryland dismissed StemCells’ patent infringement case with prejudice in StemCells Inc v Neuralstem Inc in favor of Neuralstem, on July 22, 2015. 24 July 2015
Biosimilars
The US Court of Appeals for the Federal Circuit has rejected arguments by US biotech major Amgen that Novartis failed to properly follow regulations when it sought to launch Zarxio (filgrastim-sndz). 22 July 2015
Pharmaceutical
The Ensuring Access to Clinical Trials Act of 2015, which was introduced by Senators Ron Wyden (Democrat, Oregon), Orrin Hatch (Republican, Utah), Edward Markey (Democrat, Maryland) and Sherrod Brown (Democrat, Ohio) and co-sponsored by an additional 12 Senators, was passed yesterday. 17 July 2015
Pharmaceutical
The Delhi High Court of India has upheld the patent of US pharma major Bristol Myers Squibs for Sprycel (dasatinib), reports The Economic Times of India. 14 July 2015
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has agreed to pay the United States and participating states a total of $46.5 million, plus interest, to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program, the Justice Department has announced. 8 July 2015
Pharmaceutical
The US Court of Appeals for the Federal Circuit Court has ruled against The Medicines Company in its anticoagulant Angiomax (bivalirudin) patent litigation with Hospira. 4 July 2015
Pharmaceutical
The US Department of Justice has filed a lawsuit in federal court to hit Novartis with $3.35 billion in damages and civil fines over alleged kickback schemes for Exjade (deferasirox) and Myfortic (mycophenolic acid). 1 July 2015
Pharmaceutical
Eli Lilly has announced that it had received a positive UK court ruling on the patent for its blockbuster cancer drug Alimta (pemetrexed disodium). 26 June 2015
Pharmaceutical
The former head of cybercrime at the US department of Homeland Security has warned of the increased threat to pharma and biotech companies in this area. 25 June 2015
Generics
The USA’s Federal Trade Commission last week filed an amicus brief in the US Court of Appeals for the First Circuit urging the court to reject a district court decision in a reverse-payment patent settlement case. 22 June 2015
Biosimilars
US Representative Steve Stivers (Republican, Ohio) yesterday joined Rep Peter Welch (Democrat, Vermont) to re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to increase consumer access to generic drugs, boost market competition and ultimately save consumers money. 19 June 2015
Generics
The US Court of Appeals for the Federal Circuit has again found that US Patent No 5,800,808, related to a method of manufacturing glatiramer acetate, the active ingredient of Israel-based Teva Pharmaceutical Industries blockbuster multiple sclerosis drug Copaxone, is invalid as indefinite. 18 June 2015
Pharmaceutical
Health Action International, the non-profit that represents the interests of consumers in drug policy, has expressed its disappointment at the European Parliament Committee on Legal Affairs (JURI) voting to adopt the rapporteur’s report on the European Union Trade Secrets Directive. 18 June 2015
Pharmaceutical
A state court jury in the USA has ruled that pharma giant Pfizer was not responsible for the birth defects in a child whose mother used Zoloft (sertraline) during pregnancy. 12 June 2015
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