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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 US Department of Justice on Thursday released its latest data on recoveries under the False Claims Act, saying there were nearly $2.7 billion in settlements and judgments in the 2023 fiscal year, an increase from the prior year's haul. 23 February 2024
Pharmaceutical
Biotech company United Therapeutics Corporation has launched a lawsuit against the US Food and Drug Administration (FDA). 23 February 2024
Biotechnology
The USA’s Creating Hope Reauthorization Act of 2024 was introduced in the House of Representatives last week, prompting US trade group Biotechnology Innovation Organization (BIO) chief executive and president, Rachel King, to make the following statement following the bill's introduction: 21 February 2024
Generics
The Indian Commerce Ministry confirmed has rejected of Switzerland's demand for data exclusivity for medicines in the India-EFTA trade deal, and emphasised the importance of protecting the country’s generic drug production and supply. 16 February 2024
Biotechnology
Tesaro, a subsidiary of UK pharma major GSK, has come up on top in the latest stage of its legal battle with Anglo-Swedish drugmaker AstraZeneca regarding the ovarian cancer drug Zejula (niraparib). 15 February 2024
Pharmaceutical
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has made clear its opposition to the drug price-setting provisions in the Biden administration’s Inflation Reduction Act (IRA). 14 February 2024
Pharmaceutical
Novo Nordisk has come out on top in two cases in Florida courts relating to its weight loss drug Wegovy (semaglutide). 13 February 2024
Pharmaceutical
American dermatology company Verrica Pharmaceuticals has filed a lawsuit against Canada’s Dormer Laboratories related to the active ingredient cantharidin. 5 February 2024
Pharmaceutical
Healthcare giant Johnson & Johnson has reportedly reached a tentative settlement to resolve probes by US states into whether it misled consumers about the safety of its talc products. 24 January 2024
Pharmaceutical
The US Court of Appeals for the Second Circuit yesterday affirmed a district court ruling which ordered “pharma bro” Martin Shkreli to face a lifetime ban from participating in the pharmaceutical industry. 24 January 2024
Biosimilars
Generics and biosimilars trade group Medicines for Europe and its members are strongly concerned by the first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany, in October 2023. 19 January 2024
Biotechnology
Japanese drugmaker Daiichi Sankyo yesterday announced that the US Patent and Trademark Office (US PTO) rendered a Final Written Decision invalidating all claims of Seagen’s US patent 10,808,039 (the ’039 patent) that were challenged by Daiichi Sankyo in a post-grant review proceeding (PGR). 18 January 2024
Generics
A generics drugmaker has had its Abbreviated New Drug Application for the radiopharmaceutical 177Lu-PNT2003 accepted by the US Food and Drug Administration. 12 January 2024
Pharmaceutical
Grifols, the Spanish producer of blood plasma-based products, is not taking the stock market damage done to the company by UK short seller Gotham City Research without a fight. 11 January 2024
Pharmaceutical
Tuesday was a tough day for Grifols, the Spanish producer of blood plasma-based products, as it lost 14% of its stock market value. 10 January 2024
Pharmaceutical
US pharma company Esperion Therapeutics on Wednesday announced a $125 million deal with Japanese drugmaker Daiichi Sankyo’s European subsidiary (DSE) to resolve Esperion's demand for $300 million from the company over Esperion's cholesterol reduction drugs. 4 January 2024
Biotechnology
Shares in German biopharma CureVac closed nearly 30% lower on Tuesday. 20 December 2023
Generics
With sales of lucrative immunology medicine Rinvoq (upadacitinib) topping $1 billion in the third quarter, developer AbbVie is taking action to shore up its patent estate. 23 November 2023
Pharmaceutical
The USA’s Federal Trade Commission (FTC) says it has filed an amicus brief to address the anticompetitive harm that stems from improperly listed patents in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.” 21 November 2023
Biotechnology
The European Commission has unconditionally approved the proposed $43 billion acquisition of US biotech Seagen by pharma giant Pfizer, under the EU Merger Regulation. 21 October 2023
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