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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
Biosimilars
The USA’s Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association yesterday commended the Washington State House and Senate for continuing to advance legislation designed to create a pathway for the substitution of interchangeable biologic medicines, or biosimilars. 23 January 2014
Pharmaceutical
Pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database, under draft legislation informally agreed with European Union ministers and approved by Public Health Committee Members of the European Parliament (MEPs) on Wednesday (January 22). 23 January 2014
Pharmaceutical
China's largest drug distributor, state-owned Sinopharm, has become the most high profile domestic group to face corruption charges, which have so far largely focussed on foreign drug majors. 14 January 2014
Pharmaceutical
US biopharma company Aegerion Pharmaceuticals has received a subpoena from the US Department of Justice requesting documents regarding its marketing and sale of Juxtapid (lomitapide), a drug to treat a rare cholesterol disorder, in the USA. 13 January 2014
Biotechnology
In connection with a qui tam proceeding ("whistleblower case"), Swiss biotech firm Actelion previously announced in September 2010 that its fully owned US subsidiary Actelion Pharmaceuticals US received a subpoena from the US Attorney's Office for the Northern District of California relating, among other things, to the marketing and sales practices of its leading pulmonary arterial hypertension drug Tracleer (bosentan) in the USA. 10 January 2014
Pharmaceutical
Swiss drug major Novartis faced two problems yesterday, when the Japanese Ministry of Health Labor and Welfare filed a formal criminal complaint with the public prosecutor’s office relating to its marketing of the antihypertensive drug Diovan (valsartan), and in the USA, where it was accused of paying kickbacks to a New York pharmacy company to promote its Exjade (deferasirox). 10 January 2014
Generics
With the commencement this year of manufacturing and selling generic copies of the hypercholesterolemia agent Livalo (pitavastatin) , manufactured and sold by privately-held Japanese drugmaker Kowa, the latter, along with Nissan Chemical intend to bring legal actions against the generic drug marketing authorization holders. 30 December 2013
Pharmaceutical
US drugmaker Abbott Laboratories has agreed to pay $5.475 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to implant the company’s carotid, biliary and peripheral vascular products, the US Justice Department announced on Friday (December 27). 29 December 2013
Pharmaceutical
Health care companies are leading the way in terms of public trust and transparency, according to The Red Flag Group Compliance Pulse UK report. 27 December 2013
Biotechnology
Nordic biotech firm Swedish Orphan Biovitrum (STO: SOBI) has terminated its distributor agreement with partner Rare Disease Therapeutics for Orfadin (nitisinone) in the USA, Canada, and Latin America. 20 December 2013
Generics
UK pharma giant GlaxoSmithKline and ViiV Healthcare confirmed that the US District Court for the District of Delaware has upheld the validity of a patent covering the double combination of lamivudine and abacavir (Epzicom) and the triple combination of lamivudine, abacavir and zidovudine (Trizivir). 19 December 2013
Generics
South Korea-based Hanmi Pharmaceutical has announced that Esomezol (esomeprazole strontium) for the treatment of gastroesophageal reflux disease (GERD) has launched in the USA. 18 December 2013
Generics
US pharma behemoth Pfizer says it has settled its long-standing litigation against a US subsidiary of Israeli generics giant Teva Pharmaceutical Industries relating to the patent covering the use of erectile dysfunction drug Viagra (sildenafil), which expires in April 2020 (including pediatric exclusivity). 18 December 2013
Pharmaceutical
Secrets of how Bristol-Myers Squibb and AstraZeneca arranged a behind-the-scenes deal to buy Amylin were revealed at the Genesis 2013 conference in London on Thursday. 16 December 2013
Pharmaceutical
The US House of Representatives Budget Committee Chairman Paul Ryan and Senate Budget Committee Chairman Patty Murray announced a two-year budget agreement that they say will “reduce the deficit - without raising taxes…it cuts spending in a smarter way…prevent(s) another government shutdown and roll(s) back sequestration’s cuts to defense and domestic investments in a balanced way.” 14 December 2013
article
The US Congress has been silent on new legislation addressing drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) since the US Supreme Court issued its June 2013 opinion in Federal Trade Commission versus Actavis 570, notes Kurt Karst, writing on the Hyman, Phelps & McNamara FDA Law Blog. 13 December 2013
Pharmaceutical
The US Supreme Court has stood by a $142 million ruling against US drug maker Pfizer (NYSE: PFE) over the marketing of Neurontin for epilepsy, reported Reuters. 10 December 2013
Pharmaceutical
Danish insulin giant Novo Nordisk revealed this morning that the Danish Financial Supervisory Authority today reported the company to the police for violating its obligation under Section 27 (1) of the Danish Securities Trading Act to disclose inside information as soon as possible. 10 December 2013
Pharmaceutical
US drugmaker United Therapeutics says it has received a subpoena from the Office of the Inspector General of the Department of Health and Human Services relating to marketing practices for three of its products. 9 December 2013
Biotechnology
The US trade group Biotechnology Industry Organization (BIO) has expressed grave concerns relating to the Innovation Act (HR 3309), which this week gained a strong bipartisan vote from the House Judiciary Committee. 4 December 2013
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