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Pharmaceutical
The US District Court for the District of Columbia, presiding in a law suit between Japanese drugmaker Takeda and the US Food and Drug Administration, has set an accelerated hearing to resolve the case. 10 November 2014
Pharmaceutical
Two US Senators have announced their intention to introduce a bill to speed the development of treatments and vaccines for Ebola by adding Ebola to FDA’s priority review “voucher” program, a program at the Food and Drug Administration designed to incentivize the development of new drugs for neglected tropical diseases. 30 October 2014
Pharmaceutical
A US district court has reduced the damages to be paid by Japan’s largest drugmaker Takeda Pharmaceutical and US drug major Eli Lilly. 28 October 2014
Pharmaceutical
Danish diabetes care giant Novo Nordis on Friday revealed it had been served with a subpoena by the office of the US Attorney for the District of Massachusetts. 25 October 2014
Generics
The US District Court for the District of Delaware has upheld US pharma giant Pfizer’s basic patent and the L-malate salt patent covering Sutent (sunitinib malate) capsules. 23 October 2014
Generics
Ireland-headquartered generics major Actavis confirmed that it has prevailed in a court battle over the patent on its contraceptive pill Lo Loestrin FE (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets). 23 October 2014
Biotechnology
USA-based Amgen has filed a law suit in the US District Court of Delaware against French pharma major Sanofi and US biotech Regeneron Pharmaceuticals for patent infringement of US Patent Numbers 8,563,698, 8,829,165, and 8,859,741. 19 October 2014
Generics
Ireland-headquartered generics major Actavis confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market a methylphenidate for extended-release oral suspension. 16 October 2014
Generics
The patent battle over Israel-based Teva Pharmaceutical Industries’ multiple sclerosis drug Copaxone (glatiramer acetate) was heard by the US Supreme Court yesterday. 16 October 2014
Generics
A federal judge from the US District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories. The US Department of Justice filed the consent decree on behalf of the Food and Drug Administration. 15 October 2014
Pharmaceutical
Swiss pharma major Novartis has received a penalty charge of 3 billion rupees from the Indian National Pharmaceutical Pricing Authority (NPPA) for overcharging for its painkiller Voveran (diclofenac, also sold under the Voltaren trade name). 14 October 2014
Pharmaceutical
UK specialist health care company BTG says it has settled its US patent infringement complaint against Instituto Bioclon of Mexico and USA-based Rare Disease Therapeutics (RDT) relating to its rattlesnake venom product CroFab. 10 October 2014
Biotechnology
One of the main messages from the keynote speech at the UK Bioscience Forum by Paul Drayson, chief executive of Drayson Technologies and previous minister for science and innovation, was that the country needs to give incentives for investors to hold their investment for more than 10 years. 8 October 2014
Pharmaceutical
US pharma major Bristol-Myers Squibb has successfully resolved all outstanding US patent litigation relating to efavirenz, an active ingredient contained in HIV/AIDS drugs Sustiva (efavirenz) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate). 8 October 2014
Pharmaceutical
French pharma major Sanofi has notified the US Department of Justice and the US Securities and Exchange Commission over allegations of bribery in the Middle East and East Africa. 7 October 2014
Pharmaceutical
The US subsidiary of Japan’s largest drugmaker Takeda Pharmaceuticals says that in the case of Frances Wisniewski versus Takeda Pharmaceuticals North America, et al, relating to the firm’s type 2 diabetes drug Actos (pioglitazone) Case No: 120702272, the jury found in favor of the plaintiff and awarded $2,050,000 in compensatory damages. 6 October 2014
Generics
USA-based specialty drug firm Supernus Pharmaceuticals says it has sued generic drugmaker Actavis and its subsidiaries for infringement of three patents covering its antiepileptic drug Trokendi XR. 2 October 2014
Pharmaceutical
A legal amendment which takes effect today could help to attract drug research back to the UK, according to patent and trade mark attorneys Withers & Rogers. 1 October 2014
Pharmaceutical
Intellectual Property can be vital for the success of any pharmaceutical invention. It is very important to protect your ideas, inventions and creations to prevent them being stolen or copied. 29 September 2014
Generics
Ireland-headquartered generics major Actavis has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market its Buprenorphine Transdermal System, a generic version of Purdue Pharma’s Butrans. 26 September 2014
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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