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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
In a second law suit filed against it in a matter of days, US generic drugmaker Impax Laboratories (Nasdaq: IPXL) says that Alza Corp, a subsidiary of drug major Johnson & Johnson (NYSE: JNJ), has filed suit for patent infringement against Impax in the US District Court for the District of Delaware in connection with Concerta (methylphenidate hydrochloride) extended-release 54mg tablets, a treatment for attention-deficit hyperactivity disorder (ADHD). 1 December 2010
Pharmaceutical
Switzerland-based Basilea Pharmaceutica (SIX: BSLN) announced yesterday that a Dutch arbitration tribunal has found US drug major Johnson & Johnson (NYSE: JNJ) in breach of its license agreement with the company. The tribunal awarded Basilea around $130 million as compensation for lost payments related to ceftobiprole, including milestones, other damages and interest, which is immediately enforceable. 30 November 2010
Pharmaceutical
Pharmaceutical companies that fail to submit annual reports of their marketing expenses to the Philippines Secretary of Health face a fine of 500,000 pesos ($11,415) and revocation of the manufacturer's or labeler's business permit once a new bill submitted to the country's House of Representatives become law. 26 November 2010
Generics
US generic drugmaker Par Pharmaceutical (NYSE: PRX) has entered into an exclusive supply and distribution agreement with Anglo-Swedish drug major AstraZeneca (LSE: AZN) in the USA to distribute the authorized generic version of the latter's asthma drug Accolate (zafirlukast). 24 November 2010
Generics
UK pharmaceutical giant GlaxoSmithKline (LSE: GSK) and Dr Reddy's Laboratories (NYSE: RDY) have signed an agreement relating to GSK's US oral penicillin facility and product portfolio. Financial terms and conditions of the transaction, which is expected to close in the first half of next year, were not disclosed. 24 November 2010
Pharmaceutical
The US Department of Justice has secured $3 billion in civil settlements and judgments in cases involving fraud against the government in the fiscal year ending September 30, 2010, Tony West, Assistant Attorney General for the Civil Division, announced yesterday. 23 November 2010
Pharmaceutical
Global drugs behemoth Pfizer (NYSE: PFE) has extended the expiration date of its tender offer for all outstanding shares of common stock of King Pharmaceuticals (NYSE: KG) for $14.25 per share, or around $3.6 billion, announced last month and aimed at expanding its presence in the pain relief market (The Pharma Letter October 13). 23 November 2010
Pharmaceutical
Bribery in hospitals has increased in some areas of China, seriously undermining people's interests and the image of medical professionals, according to a report. In the People's Daily last week 23 November 2010
Pharmaceutical
According to data from FreightWatch, a USA-based freight security consultancy, rising demand in the USA for expensive medicines since the economic downturn has helped make pharmaceutical shipments a growing target for organized criminal gangs. 23 November 2010
Pharmaceutical
Doctor's surgery remains the most typical place where doctors are willing to meet representatives of pharmaceutical companies. On the other hand, most doctors have also heard of modern forms of pharma marketing, according to a survey conducted by market research group PMR among doctors in Poland, the results of which have been presented in the report titled Modern and traditional forms of effective pharmaceutical marketing. 23 November 2010
Pharmaceutical
Last month's settlement of a case against a major pharmaceutical company, UK giant GlaxoSmithKline (LSE: GSK), regarding production violations has ignited increased concern from the US Food and Drug Administration, comments South Africa-based www.stockcall.com. 23 November 2010
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) said on Friday that a federal court jury in New York found in its favor in the Graves versus Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems, osteonecrosis, on her use of the firm's Fosamax (alendronate). 22 November 2010
Generics
The European Medicines Agency yesterday hosted the third EMA-EGA (European Generic Medicines Association) Info Day. There has been growing interest in the European generic medicines industry's use of the Centralised Procedure in order to obtain a Marketing Authorization that is valid in all the European Economic Area (EEA) markets. 11 November 2010
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) says that a federal appellate court ruled in its favor in a patent infringement suit against Barr Laboratories, a subsidiary of Israeli generics major Teva Pharmaceuticals Industries (Nasdaq: TEVA) relating to its brain cancer drug Temodar (temozolomide). 11 November 2010
Pharmaceutical
An attorney for a major pharmaceutical company was charged with obstruction and making false statements, the US Department of Justice announced yesterday. Lauren Stevens of Durham, North Carolina, was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration. 10 November 2010
Pharmaceutical
US Attorney for the Northern District of New York Richard Hartunian says that a former employee of US drug major Bristol-Myers Squibb (NYSE: BMY) has pleaded guilty to theft of the company's trade secrets. 9 November 2010
Pharmaceutical
Dozens of families in Britain, who blame an epilepsy drug for causing birth defects in their children, say they are devastated that legal aid to sue its maker has been withdrawn, the UK's public broadcaster the BBC revealed this morning. 8 November 2010
Pharmaceutical
Cannabis Science (OTC Bulletin Board:CBIS.ob), a US biotech company developing pharmaceutical cannabis products, says that, regardless of the outcome of Proposition 19 in California and other marijuana-related electoral issues throughout the country, it is apparent that that the Cannabis Science Food and Drug Administration clinical trials initiatives are more important than ever, as the demand for the firm's pharmaceutical products for critical ailments may reach an all time high. 8 November 2010
Generics
Anglo-Swedish major AstraZeneca (LSE: AZN) says the US Court of Appeals for the Federal Circuit affirmed the District Court's issuance of a preliminary injunction barring Canada-headquartered Apotex from launching a generic version of the firm's Pulmicort Respules (budesonide inhalation suspension) in the USA. 3 November 2010
Biotechnology
As part a new legislation that was signed this week by the government of Puerto Rico, Law 154, it is proposed to levy a 4% tax on foreign corporations. Puerto Rico's Governor Luis Fortuno unveiled the fiscal package as part of an economic development and budget-deficit reduction plan for the commonwealth. 29 October 2010
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