Legal
Refine Search
Generics
Netherlands-based Centrient Pharmaceuticals has announced that the Delhi High Court in India has granted an injunction against Sinopharm Weiqida Pharmaceuticals and Sinopharm India, restricting the export and/or import into India of its active pharmaceutical ingredient (API) amoxicillin trihydrate. 19 February 2019
Pharmaceutical
American charity AIDS Healthcare Foundation (AHF) has claimed victory in litigation against Gilead Sciences (Nasdaq: GILD), related to the firm’s promotion of its tenofovir disoproxil fumarate (TDF) based HIV/AIDS medications. 15 February 2019
Biotechnology
The USA lobby group Biotechnology Innovation Organization (BIO) released a new report, “Science or Compliance: Will Section 404(b) Compliance Impede Innovation by Emerging Growth Companies in the Biotech Industry?” on Monday, coinciding with National Inventor’s Day. 12 February 2019
Generics
Ireland-incorporated drugmaker Endo International has announced that the US Food and Drug Administration (FDA) has requested a further stay of Endo's ongoing litigation against the FDA through March 15. 7 February 2019
Generics
London-listed addiction specialist Indivior failed in its bid to block a generic competitor to its Suboxone film drug, used in the treatment of opioid addiction. 6 February 2019
Pharmaceutical
The US courts have not been a happy place for life sciences company Bayer since acquiring agribusiness giant Monsanto due to legal action being taken over the glyphosate-based weed killer Roundup, which allegedly causes cancer. 6 February 2019
Biotechnology
USA-based Puma Biotechnology has announced that the class action lawsuit, Hsu vs Puma Biotechnology Inc, et al, filed in the US District Court for the Central District of California against Puma and Alan Auerbach, Puma’s chief executive and president, has concluded with a jury verdict that is largely positive for the company. 5 February 2019
Biotechnology
Danish biotech Genmabrevealed on Thursday that the patent infringement lawsuit launched by Germany-based MorphoSys relating to Darzalex (daratumumab) is finally over. 1 February 2019
Pharmaceutical
In a unanimous opinion, the US Supreme Court solidified that inventors lose patent protection for inventions that they had sold or offered to sell more than a year before submitting the patent application - even if those sales were confidential and did not publicize the invention’s details. 23 January 2019
Pharmaceutical
A powerful committee of the freshly inaugurated Democrat-led US House of Representatives has launched a far-ranging investigation into the drug pricing practices of the US pharmaceutical industry. 15 January 2019
Pharmaceutical
The beginning of a new year is a moment to dust off yearly strategies and to jot down the list of what needs to be done over the next 12 months. 14 January 2019
Generics
Swedish drug developer Orexo today announces that the US District Court for the District of Delaware has issued a final, non-appealable judgement that Actavis’ generic Zubsolv products infringe Orexo’s US patent No 8,940,330. 11 January 2019
Pharmaceutical
A former chief executive of US specialty pharma firm Insys Therapeutics has entered a guilty plea to allegations of conspiring to bribe physicians to prescribe the addictive opioid Subsys, an under-the-tongue fentanyl spray for managing severe pain in cancer patients. 10 January 2019
Pharmaceutical
Madrid-based PharmaMar has launched a legal action against the European Commission to try to secure European Medicines Agency (EMA) approval for Aplidin (plitidepsin). 10 January 2019
Pharmaceutical
Imogen Ireland, life sciences IP associate for law firm Hogan Lovells, raises some important issues relating to advances in artificial intelligence (AI) that drugmakers may not have fully considered, in an Expert View piece. 9 January 2019
Generics
Israeli generics giant Teva Pharmaceutical Industrie announced that it has resolved its ongoing dispute with Amgen over Teva’s generic cinacalcet HCl, 3 January 2019
Generics
Ironwood Pharmaceutical and Allergan have reached an agreement with Mylan Pharmaceuticals resolving patent litigations brought in response to Mylan’s Abbreviated New Drug Applications (ANDAs) approval to market generic versions of Linzess (linaclotide) prior to the expiration of the companies’ applicable patents. 3 January 2019
Generics
Endo International today announced that, due to the ongoing federal government shutdown, the US Food and Drug Administration has requested a further stay of Endo's ongoing litigation against the FDA for the duration of the shutdown. 31 December 2018
Pharmaceutical
DUSA Pharmaceuticals, a wholly-owned subsidiary of Sun Pharmaceutical Industries, has been granted preliminary injunctive relief by a federal district court prohibiting defendants Germany-based skin cancer specialist Biofrontera and its subsidiaries from using DUSA's confidential and proprietary trade secret information. 27 December 2018
Pharmaceutical
The US Department of Justice obtained more than $2.8 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2018, it was announced on Friday. 24 December 2018
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze