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Generics
The General Court of the European Union has upheld a 2013 decision to fine the Danish central nervous system specialist Lundbeck for violating competition law over its anti-depressant drug Cipramil (citalopram). 8 September 2016
Pharmaceutical
In the wake of steep price increases and Congressional investigations, New York Attorney General Eric Schneiderman announced that his office has commenced an investigation into the US unit of Netherlands-incorporated Mylan the maker of EpiPens. 7 September 2016
Generics
Netherlands-incorporated Mylan has received another boost in its aim to market a generic version of Teva Pharmaceutical Industries' multiple sclerosis (MS) treatment Copaxone (glatiramer acetate) 40 mg/mL. 2 September 2016
Generics
Ireland-incorporated Allergan and its partner Adamas Pharmaceuticals have come to a settlement with privately-held US generics drugmaker Amneal Pharmaceuticals over a copy of Alzheimer’s disease drug Namzaric (memantine and donepezil hydrochloride). 31 August 2016
Generics
The US Patent and Trademark Office (PTO) has ruled in favor of Netherlands-incorporated Mylan by invalidating two of Teva Pharmaceutical Industries' patents for the multiple sclerosis (MS) treatment Copaxone (glatiramer acetate). 25 August 2016
Generics
Canada's battered drugmaker Valeant Pharmaceuticals International has had some good news in the shape of lender consent for an amendment to its credit facility, but it comes in the midst of accusations from its former shareholder T Rowe Price. 22 August 2016
Biotechnology
Proposed new legislation which aims to promote faster patient access to effective new cellular therapies fails to adequately address safety and efficacy concerns, according to the International Society for Cellular Therapy (ISCT). 19 August 2016
Biosimilars
Johnson & Johnson has confirmed a negative US court ruling relating to a biosimilar version of its blockbuster rheumatoid arthritis drug Remicade (infliximab). 18 August 2016
Pharmaceutical
In the USA, the Delaware District Court confirmed the validity of US patent RE38,551 related to Vimpat (lacosamide), Belgian pharma company UCB’s anti-epileptic drug. 15 August 2016
Pharmaceutical
Swiss pharma giant Novartis could face a South Korean sales ban over the actions of staff at its subsidiary in the Asian country. 12 August 2016
Pharmaceutical
Beleaguered Canadian drugmaker Valeant is being investigated by prosecutors over claims that it conned insurers by hiding its ties to the mail-order pharmacy Philidor Rx Services to boost drug sales. 12 August 2016
Biosimilars
US drugmaker AbbVie has launched legal proceedings to prevent rival company Amgen from marketing a biosimilar version of its blockbuster arthritis drug Humira (adalimumab). 8 August 2016
Pharmaceutical
The US Chamber of Commerce and the Texas Association of Business have filed a legal challenge to the Internal Revenue Service’s immediately effective Multiple Acquisition Rule, which attempts to prevent certain corporate mergers that are otherwise permitted under the inversion rules under Section 7874 of the Internal Revenue Code. 5 August 2016
Generics
US State of Georgia Attorney General Sam Olens yesterday announced that Georgia has joined 47 other states in a $125 million settlement with drug manufacturer Cephalon and affiliated companies. 5 August 2016
Pharmaceutical
The High Court in Britain has overturned a decision by NHS England to remove Pre-Exposure Prophylaxix (PrEP) for HIV from its commissioning process. 2 August 2016
Generics
Mylan has agreed to divest the rights and assets related to two generic pharmaceutical products to settle US Federal Trade Commission charges that its proposed $7.2 billion acquisition of Swedish drugmaker Meda would be anti-competitive. 29 July 2016
Generics
USA-based Vivus says it has filed a lawsuit in the US District Court for the District of New Jersey against Hetero USA Inc and Hetero Labs, units of Indian generics drugmaker Hetero. 28 July 2016
Generics
The US Federal Trade Commission (FTC) has approved Teva Pharmaceutical Industries’ takeover of the generics arm of Ireland-incorporated Allergan – subject to the Israeli company’s divestment of dozens of generic drugs. 28 July 2016
Pharmaceutical
More than 400 women have come forward over the past month to join a class action lawsuit against US pharma giant Merck & Co, lawyers have revealed. 26 July 2016
Pharmaceutical
Brexit has sent shockwaves through the pharmaceutical and life science industries and although the exact extent of the fallout is not yet known, the impact is sure to be felt for many years to come. Exactly a month on from one of the most significant votes in British history, the Pharma Letter takes a look at the immediate aftermath of the decision and some of the potential long term implications. 23 July 2016
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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