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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
AstraZeneca has failed to convince a US judge to issue a temporary restraining order blocking the approval of new generic versions of the company’s blockbuster cholesterol drug Crestor (rosuvastatin calcium) in the USA. 21 July 2016
Pharmaceutical
The Treat and Reduce Obesity Act aims to improve access to weight management therapy. Over the last few years, obesity has become the hot button issue that legislators can set their sights on and pass meaningful legislation on without ruffling too many feathers, writes Dr Nicolas Davies in her monthly exclusive FDA Blog for The Pharma Letter. 18 July 2016
Pharmaceutical
The US Food and Drug Administration, at a public meeting on Friday, issued a document that contains the performance goals and procedures for the Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs) 2018-2022, known as PDUFA VI. It is commonly referred to as the “goals letter” or “commitment letter.” 16 July 2016
Generics
AstraZeneca has reached an agreement with Sandoz, a division of Swiss pharma giant Novartis, over the US development of a generic version of the breast cancer drug Faslodex (fulvestant). 14 July 2016
Pharmaceutical
The US Court of Appeals for the Federal Circuit Court, in an en banc review, unanimously affirmed the earlier district court ruling in The Medicines Company v Hospira, finding that the company's Orange Book patents covering Angiomax (bivalirudin) that expire in 2028 (pediatric exclusivity expiring in 2029) were not invalid under the "on sale" bar. 13 July 2016
Biosimilars
The non-profit AIDS Healthcare Foundation (AHF) will appeal the dismissal of its federal lawsuit against US biotech major Gilead Sciences and other defendants alleging drug patent manipulation and anti-trust claims relating to slightly different formulations of the HIV drug tenofovir. 12 July 2016
Biosimilars
The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration review. 8 July 2016
Biotechnology
The Court of Justice of the European Union has judged that the beneficiary of a patent license must pay the agreed royalty even if it does not infringe on the patent technology. 7 July 2016
Biosimilars
After a series of hearings, the Court of Appeals of Sri Lanka has finally dismissed the claims from Swiss pharma giant Roche (ROG: SIX) in a lawsuit seeking to stop distribution of the Russian-made anti-tumor biosimilar products, as well as seeking to revoke Biocad’s product market authorization in Sri Lanka for the anti-cancer drugs trastuzumab and bevacizumab. 5 July 2016
Generics
Earlier this week, iPR Pharmaceuticals, the owner of NDA 021366 for Crestor (rosuvastatin calcium) and Anglo-Swedish pharma major AstraZeneca (LSE: AZN), which markets the cholesterol drug, filed a Complaint a in the US District Court for the District of Columbia seeking to block the US Food and Drug Administration’s approval of Abbreviated New Drug Applications (ANDAs) for generic Crestor tablets. 30 June 2016
Biotechnology
US Representative Jan Schakowsky and US Senators Sherrod Brown and John McCain have introduced legislation aimed at helping to lower prices of life-saving drugs and save taxpayers billions of dollars over the next 10 years. 24 June 2016
Pharmaceutical
The German Federal Supreme Court has granted the appeal by US pharma major Eli Lilly in the case of Eli Lilly and Company v Actavis, vacating the prior decision denying infringement. 16 June 2016
Generics
The US Senate Judiciary Committee introduced new legislation Tuesday, aimed at countering the growing issue of rising prescription drug prices in the USA and anti-competitive moves by pharmaceutical companies to delay lower-priced generic competition from entering the market. 15 June 2016
Pharmaceutical
Sanofi this morning announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) in connection with Sanofi's intent to acquire Medivation. 14 June 2016
Biosimilars
Leading Russian biotech firm Biocad has filed a petition to the New York Federal Court against Swiss pharma giant Roche, accusing the company of setting monopoly-low prices for its products in Russia, with the aim of ruining business of local competitors, reports The Pharma Letter’s local correspondent. 14 June 2016
Generics
Drug pricing was on Wall Street’s mind again Friday, as Wells Fargo tapped Netherlands-incorporated Mylan as the next target for activists, reported Investor’s Business Daily. 13 June 2016
Pharmaceutical
By Barbara Obstoj-Cardwell. Editor
Sarepta Therapeutics and top officials at the US Food and Drug Administration are working cooperatively to approve the Duchenne muscular dystrophy drug eteplirsen, wrote Adam Feuerstein on TheStreet blog. 12 June 2016
Biotechnology
A judge in the USA has freed biotech major Gilead Sciences from having to pay $200 million over allegedly infringing the hepatitis C patents of Merck & Co. 7 June 2016
Pharmaceutical
UK based Indivior on Friday received a favorable ruling in the District Court of Delaware in the ANDA litigation against Actavis Laboratories and Par Pharmaceutical relating to Suboxone (buprenorphine and naloxone) its treatment for opioid addiction. 4 June 2016
Generics
The UK’s Competition and Markets Authority (CMA) has told The Pharma Letter that it continues to investigate suspected excessive pricing in the pharmaceutical industry. 3 June 2016
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