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Debbie Feinstein, the Director of the Federal Trade Commission’s Bureau of Competition, issued the following statement regarding this week’s decision by the US Court of Appeals for the District of Columbia Circuit upholding a November 2013 FTC rulemaking that deems the transfers of pharmaceutical patent rights to be reportable assets under the Hart-Scott-Rodino Act – even if the sellers retain some manufacturing rights. 11 June 2015
Generics
Orexigen Therapeutics and partner, Japan’s Takeda Pharma have filed a law suit in the US District Court for the District of Delaware against generics major Actavis. 6 June 2015
Biotechnology
The federal district court for the District of Columbia has granted US biotech firm Amarin’s motion for summary judgment in the company's law suit against the US Food and Drug Administration. 30 May 2015
Generics
The US Federal Trade Commission has reached a settlement resolving its antitrust suit charging Cephalon with illegally blocking generic competition to its blockbuster sleep-disorder drug Provigil (modafinil). 29 May 2015
Generics
The US Court of Appeals for the Federal Circuit has upheld the District Court of Delaware’s earlier ruling on Par Pharmaceuticals’ generic of Exelon (rivastigmine transdermal system), manufactured by Novartis. 27 May 2015
Pharmaceutical
A panel of the US Court of Appeals for the Second Circuit has issued a ruling upholding a December 15, 2014, preliminary injunction requiring Ireland-headquartered generics major Actavis to continue distribution of its Alzheimer’s disease drug Namenda (memantine HCl) immediate-release tablets. 25 May 2015
Pharmaceutical
US law firm Shernoff Bidart Echeverria Bentley yesterday filed a law suit in the Los Angeles Superior Court accusing health insurer Blue Cross of withholding a cure for hepatitis C based only upon profits, in violation of California law. 19 May 2015
Generics
Ireland-headquartered generics major Actavis yesterday said that it will immediately re-launch its generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) following a decision from the US Court of Appeals. 8 May 2015
Pharmaceutical
Cardiovascular biopharma specialist Amarin and four independent physicians have filed a law suit to permit off-label promotion. 8 May 2015
Biosimilars
The US Court of Appeals for the Federal Circuit issued an injunction this week blocking Swiss pharma major Novartis’ US generics subsidiary Sandoz Inc from selling a biosimilar version of Amgen’s drug Neupogen (filgrastim) 7 May 2015
Generics
Japanese drug major Eisai has entered into a settlement agreement with Indian drugmaker Glenmark Pharmaceuticals and its US subsidiaries to resolve their patent litigation relating to Eisai's Banzel (rufinamide) in the USA. 1 May 2015
Pharmaceutical
A US bipartisan senate group has released a new patent reform bill to address abusive patent litigation. 30 April 2015
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical and its US subsidiary, have reached an agreement expected to resolve the vast majority of Actos (pioglitazone) product liability law suits pending against Takeda in the USA. 29 April 2015
Generics
TWi Pharmaceuticals has entered into a settlement agreement with Takeda Pharmaceuticals to settle and dismiss all outstanding patent litigation related to TWi's generic dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths. 27 April 2015
Generics
Israel-based Teva Pharmaceutical Industries has agreed a $512 million settlement in a class-action law suit in which a company it owns was accused of delaying the launch of Provigil (modafinil). 21 April 2015
Pharmaceutical
US pharma giant Pfizer has won its first trial in the USA relating to claims that its antidepressant Zoloft (sertraline) caused birth defects. 20 April 2015
Pharmaceutical
USA-based Pacira Pharmaceuticals revealed that it has received a subpoena from the US Department of Justice, US Attorney’s Office for the District of New Jersey. 19 April 2015
Generics
US specialty drugmaker Depomed has entered into a settlement agreement with Actavis in patent infringement litigation related to Actavis' Abbreviated New Drug Application seeking approval to market generic versions of Depomed's Gralise (gabapentin). 13 April 2015
Pharmaceutical
Swiss sdrug major Novartis has reached a settlement agreement with Juno Therapeutics over a chimeric antigen receptor technology (CAR-T) for oncology. 7 April 2015
Generics
US drugmaker The Medicines Company says it has settled its litigation with India’s Sun Pharmaceutical Industries and certain of its subsidiaries relating to MDCO’s US patents covering the anticoagulant Angiomax (bivalirudin). 2 April 2015
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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