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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
Generics
Denmark-based CNS specialist drugmaker Lundbeck (LUND: CO) has filed its appeal against the European Commission with the General Court, with the aim of having the decision that the company had violated violated European Union antitrust rules that prohibit anticompetitive agreements (Article 101 of the Treaty on the Functioning of the European Union - TFEU) annulled and/or the fine of 93.8 million euros ($111.2 million at current exchange rates) reduced (The Pharma Letter June 19). 2 September 2013
Biotechnology
In the USA this week, the California Assembly has passes legislation that would allow pharmacists to dispense biosimilars, substitute medicines that are biologically similar to brand-name treatments, after notifying prescribing doctors, according to various media reports. SB598 passed the Assembly on Monday on a 58-four vote and returns to the Senate for a final vote. 29 August 2013
Pharmaceutical
In the ongoing allegations of bribery and corruption by multinational drugmakers in China, US pharma major Eli Lilly (NYSE: LLY) is the latest to be implicated, with the company saying it is "deeply concerned" by claims that it bribed doctors to prescribe its drugs. 23 August 2013
Pharmaceutical
Canadian specialty pharma company Nuvo Research (TSX: NRI) says it has commenced legal action against USA-based Mallinckrodt (NYSE: MNK) by filing a complaint in the US District Court for the Southern District of New York. 21 August 2013
Generics
The US Federal Trade Commission has asked the US District Court for the District of New Jersey to accept an amicus brief that addresses the application of the US Supreme Court's recent ruling in FTC versus Actavis to a patent settlement containing a "no-authorized-generic" commitment. The FTC submitted the brief in the case of In re Effexor XR Antitrust Litigation. 21 August 2013
Pharmaceutical
As largely expected, Brazilian President Dilma Rousseff has signed the Brazilian Clean Companies Act, according to a comprehensive report from law firm Covington & Burling, which, though not specifically targeted as the sector, will clearly have implications for pharmaceutical companies, both domestic firms and multinationals doing business in that country. 15 August 2013
Pharmaceutical
Following last week's whistleblower allegations that French drug major Sanofi (Euronext: SAN) had paid bribes to Chinese doctors (The Pharma Letter August 9), the Beijing municipal authorities have set up a joint investigation team to probe the company's activities, reports Xinhau, the official Chinese news agency. 12 August 2013
Pharmaceutical
In the wake of allegations that several multinational pharma companies have engaged in unlawful marketing practices, including bribery, in China, an anonymous whistleblower, identified only through a false name "Pei Gen," told the 21st Century Business Herald newspaper that staff at French drug major Sanofi's (Euronext: SAN) Chinese subsidiary paid bribes totalling around 1.7 million renminbi ($277,800) to 503 doctors at 79 hospitals in Shanghai, Beijing, Hangzhou and Guangzhou in late 2007, according to a Reuters report. 9 August 2013
Biotechnology
The USA-based AIDS Healthcare Foundation (AHF) says it won a key legal victory in a push for drug safety as well as increased government transparency when a federal court ruled that the Food and Drug Administration illegally blocked Freedom of Information Act (FOIA) requests tendered by the AHF regarding correspondence between the FDA and drugmaker Gilead Sciences (Nasdaq: GILD). 8 August 2013
Biotechnology
In the USA last week, Mark Pryor (Democrat, Arkansas), chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, and Senators Roy Blunt, (Republican, Missouri), Daniel Coats (Rep, Indian), Al Franken (Dem, Minnesota), and Jerry Moran (Rep, Kansas) introduced S 1413 to exempt future Food and Drug Administration (FDA) user fees from sequestration. 5 August 2013
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) has confirmed that India's Intellectual Property Appellate Board (IPAB) today (August 2) has issued an order revoking a patent on its breast cancer drug Tykerb (lapatinib), marking another setback for research-based drugmakers in protection their intellectual property in that country. 2 August 2013
Pharmaceutical
Wyeth Pharmaceuticals, a US pharma rival acquired by US behemoth Pfizer (NYSE:PFE) in 2009, has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune (sirolimus), which the company illegally promoted for uses not approved as safe and effective by the US Food and Drug Administration, the Justice Department revealed yesterday (July 30). 31 July 2013
Generics
Israel-based generics giant Teva Pharmaceutical Industries ((NYSE: TEVA) said on Friday (July 26) that the US Court of Appeals for the Federal Circuit has affirmed the judgment of the US District Court for the Southern District of New York in the appeal filed by Momenta Pharmaceuticals (Nasdaq: MNTA), Sandoz (the generics unit of Swiss drug major Novartis [NOVN: VX]) and Mylan Laboratories (Nasdaq: MYL) and Indian drugmaker Natco Pharmaceuticals regarding the validity and infringement of four patents for Teva's relapsing-remitting multiple sclerosis (RRMS) product, Copaxone (glatiramer acetate injection) that expire in May 2014. 28 July 2013
Pharmaceutical
The extent of the alleged bribery and tax-related violations by UK pharma major GlaxoSmithKline (LSE: GSK) in China has been revealed by China's Ministry of Public Security, according to China's state news agency Xinhua. 26 July 2013
Generics
US generics firm Mylan (Nasdaq: MYL) has entered into a settlement agreement with OSI Pharmaceuticals, a subsidiary of Japan's Astellas (TYO: 4503), Pfizer (NYSE: PFE) and Roche (ROG: SIX) subsidiary Genentech that will resolve patent litigation related to erlotinib hydrochloride tablets, 25mg, 100mg and 150mg. 24 July 2013
Generics
The Federal Trade Commission told a Senate Judiciary subcommittee yesterday (July 23) that it will continue to challenge anticompetitive pay-for-delay court settlements in the pharmaceutical industry, and that the recent US Supreme Court decision in FTC v Actavis (The Pharma Letter June 18) "is an important victory for consumers and a vindication of basic antitrust and free market principles." 24 July 2013
Generics
US generic drugmaker Mylan (Nasdaq: MYL) today (July 23) announced that the US Third Circuit Court of Appeals has reversed a summary judgment ruling dismissing Mylan's claim for breach of contract against UK pharma giant GlaxoSmithKline (LSE: GSK) relating to paroxetine hydrochloride extended-release (ER) tablets, an antidepressant marketed by GSK as Paxil and Seroxat. 23 July 2013
Pharmaceutical
Sales staff at UK pharma major GlaxoSmithKline (LSE: GSK) in China may have broken Chinese law, the company has admitted, as the investigation into bribery allegations continued. 22 July 2013
Biotechnology
A bipartisan group of US House of Representatives Members last week introduced the FDA Safety Over Sequestration Act, or FDA SOS Act, which exempts Food and Drug Administration user fees from sequestration. FDA user fees are 100% industry-financed and are used specifically for the approval of safe and effective drugs and devices. Under sequestration, the FDA is set to lose $85 million in user fees in fiscal year 2013 alone. 22 July 2013
Pharmaceutical
China's probe into UK pharma major GlaxoSmithKline (LSE: GSK) was part of the country's efforts to improve business climate and create equal competition opportunities for domestic and overseas investors, said a commerce official reported by the Chinese news agency Xinhua. 17 July 2013
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