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Biotechnology
Japanese drugmaker Daiichi Sankyo revealed that it has been ordered by a Texas district court to pay royalties on its antibody-drug conjugate (ADC) to US biotech Seagen. 19 October 2023
Biotechnology
One big challenge for pharma companies doing cross-border businesses in China and the USA is the respective cybersecurity law imposed by the two countries. 12 October 2023
Biotechnology
Privately-held Swiss dermatology company Galderma has announced some bad news relating to its pending Biologics License Application (BLA) for relabotulinumtoxinA (QM-1114) to the US Food and Drug Administration (FDA). 3 October 2023
Pharmaceutical
In the USA, British drugmaker AstraZeneca has brought to an end certain product liability lawsuits for the gastrointestinal meds Nexium (esomeprazole) and Prilosec (omeprazole). 3 October 2023
Biotechnology
The US Court of Appeals for the Federal Circuit has quashed an appeal from the Takeda unit Baxalta in relation to Roche’s hemophilia treatment Hemlibra (emicizumab). 22 September 2023
Pharmaceutical
US pharma major Eli Lilly has revealed it suing spas, wellness centers and compounding pharmacies selling unapproved and compounded versions of its type 2 diabetes drug Mounjaro (tirzepatide). 20 September 2023
Generics
Following scrutiny from Democratic senators in Congress, the US Federal Trade Commission has issued a policy statement on the proper listing of pharmaceutical patents. 18 September 2023
Pharmaceutical
While legal challenges surrounding the implementation of the Inflation Reduction Act (IRA) continue to mount, the Centers for Medicare & Medicaid Services (CMS) has touted the success of the program. 15 September 2023
Pharmaceutical
Swiss drugmaker Novartis has launched legal action against the US government, after administrators revealed the first drugs to be subject to pricing regulations mandated by the Inflation Reduction Act (IRA). 7 September 2023
Pharmaceutical
Japanese pharma major Astellas Pharma revealed that it has requested that the Court dismiss the company’s lawsuit challenging the constitutionality of certain provisions of the US government’s Inflation Reduction Act (IRA). 7 September 2023
Biotechnology
The US Federal Trade Commission today announced it has reached a proposed consent order with Amgen to address what the agency saw as potential competitive harm that would result from the biotech major’s $27.8 billion acquisition of Horizon Therapeutics. 1 September 2023
Pharmaceutical
Ireland-incorporated specialty pharma firm Mallinckrodt Pharmaceuticals said last week that it planned to file for bankruptcy for the second time in three years. 27 August 2023
Biotechnology
US trade body the Biotechnology Innovation Organization (BIO) said on Friday that it has filed an amicus brief opposing the Federal Trade Commission (FTC) lawsuit to block Amgen’s proposed acquisition of Horizon Therapeutics for $27.8 billion, arguing that the FTC’s overreach threatens the merger and acquisition activity that is the lifeblood of biotech innovation. 26 August 2023
Pharmaceutical
The list of companies and groups that are suing the US government over its Medicare price-setting policies continues to grow. 25 August 2023
Biosimilars
An Expert View from Róbert Wessman, founder and chairman of Icelandic biosimilars company Alvotech and investment fund Aztiq. 23 August 2023
Generics
The US Department of Justice (DoJ) yesterday announced deferred prosecution agreements (DPAs) resolving criminal antitrust charges against the US subsidiaries of Israel’s Teva Pharmaceutical Industries and India’s Glenmark Pharmaceuticals. 22 August 2023
Pharmaceutical
UK addiction treatment specialist Indivior (LSE/Nasdaq: INDV) saw its shares edge up 3% to 1,812 pence by early afternoon, as it revealed a resolution to the claims brought by the end payor class of litigants in the In re Suboxone Antitrust Litigation multi-district litigation (MDL). 21 August 2023
Pharmaceutical
The USA’s Fifth Circuit Court of Appeals on Wednesday rejected an extraordinary decision blocking the US Food and Drug Administration's (FDA) decades-old approval of the widely used abortion medication mifepristone, but also upheld the decision's reinstatement of restrictions on access to the medication. 17 August 2023
Generics
The UK’s Competition and Markets Authority (CMA) has welcomed the landmark judgment, which endorses all the main elements of the CMA’s decision in respect of liothyronine tablets – an essential medicine to treat thyroid hormone deficiency. 17 August 2023
Generics
US pharma giant Pfizer and the Scripps Research Institute have accused generics company Dexcel Pharma Technologies of patent infringement. 14 August 2023
Biotechnology
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
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