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Generics
The US affiliate of Teva Pharmaceutical Industries announced today the launch of an authorized generic of Victoza (liraglutide injection 1.8mg), in the USA. 24 June 2024
Generics
Danish specialty pharma company Xellia Pharmaceuticals, which is owned by Novo Holdings, today revealed that the US Court has vacated the Modified Consent Decree imposed on Xellia’s Cleveland, Ohio, USA facility in 2016. 29 April 2024
Generics
Swiss generic and biosimilar medicines maker Sandoz today opened a new production facility in Kundl, Austria, to serve more patients with affordable life-saving drugs produced entirely in Europe. 21 March 2024
Generics
Advancing complex generic drug development is a critical part of the US Food and Drug Administration’s (FDA) goal to help patients access safe, effective and high-quality generic medicines, the agency stated. 9 February 2024
Generics
Indian drugmaker Sun Pharmaceutical has increased its bid to acquire Israeli generics firm Taro Pharma, up to $43 per share from its previous offer of $38 per share. 14 December 2023
Generics
Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, the US Food and Drug Administration (FDA) has determined the risk evaluation and mitigation strategy (REMS) for the drugs are no longer necessary to ensure the benefits outweigh the serious risks of ischemic colitis and serious complications of constipation. 9 September 2023
Generics
Privately-held UK headquartered Advanz Pharma has signed an exclusive licensing and supply agreement with GP Pharm for a peptide specialty injectable generic in a rare disease indication for multiple European countries. 4 September 2023
Generics
A California federal jury cleared Gilead Sciences and Teva Pharmaceutical Industries on Friday in a $3.6 billion antitrust case claiming the pharmaceutical giants struck an illegal "pay for delay" patent deal that inflated prices for two HIV medications. 1 July 2023
Generics
Indian drugmaker Lupin Limited has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for tiotropium bromide inhalation powder, 18 mcg/capsule, a generic equivalent of German pharma major Boehringer Ingelheim’s Spiriva HandiHale. 22 June 2023
Generics
Today, the US Food and Drug Administration published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). 13 June 2023
Generics
Juno Pharmaceuticals Canada has purchased Omega Laboratories, a specialist injectable pharmaceutical manufacturer in Canada, for an undisclosed sum. 19 May 2023
Generics
Japanese drug major Astellas Pharma today confirmed that the US Court of Appeals for the Federal Circuit (CAFC) issued a Mandate that officially ends the CAFC appeal on patent infringement of Lexiscan (regadenoson injection) 0.4mg/mL. 11 May 2023
Generics
RedHill Biopharma has published new data for its antibiotic Talicia (omeprazole/amoxicillin/rifabutin), focused on differentiating the brand from generic alternatives. 10 May 2023
Generics
Indian drugmaker Lupin Limited says it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2mg/mL of Hikma Pharmaceuticals. 9 February 2023
Generics
Japanese drugmaker Chugai Pharmaceuticals, which is majority-owned by Roche, says that the Intellectual Property High Court has rendered judgment to dismiss the plaintiff’s appeal filed on June 9, 2022, regarding generic drugs to an osteoporosis agent, active vitamin D3 derivative Edirol (eldecalcitol) Capsule 0.5µg/0.75µg. 14 December 2022
Generics
The US Food and Drug Administration (FDA) yesterday published the draft guidance for industry, titled “Statistical Approaches to Establishing Bioequivalence,” which provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. 3 December 2022
Generics
New Jersey, USA-based Amneal Pharmaceuticals today said it has launched commercial operations in India. 10 October 2022
Generics
The US Food and Drug Administration has published more information related to recent changes to Generic Drug User Fee Amendments (GDUFA). 7 October 2022
Generics
UK provider of niche generic and branded specialty pharmaceuticals Aspire Pharma says it has completed its acquisition of privately-held Morningside Pharmaceuticals (Loughborough), Morningside Healthcare (Leicester) and Morningside Healthcare (India). 3 October 2022
Generics
The Court of Appeals for the Federal Circuit ruled in favor of Merck & Co in a patent challenge brought by Mylan Pharmaceuticals (now Viatris) related to sitagliptin dihydrogen phosphate, an active ingredient in Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride) and Janumet XR (sitagliptin and metformin hydrochloride extended-release). 30 September 2022
Generics
Fast-growing contract development and manufacturing organization (CDMO), Bora Pharmaceuticals, has completed the acquisition of fellow Taiwan based TWi Pharmaceutical, a technology-based company specializing in development and commercialization of niche generic drugs. 13 September 2022
Generics
Indian drugmaker Zydus Lifesciences has been granted approval by the US Food and Drug Administration (FDA) to market lenalidomide capsules. 13 September 2022
Generics
German drugmaker STADA Arzneimittel is broadening its offering to patients, pharmacists and physicians in Europe by introducing abiraterone acetate 500mg film-coated tablets in 21 European countries. 9 September 2022
Generics
Indian drugmaker Dr Reddy’s Laboratories has launched a generic version of Bristol Myers Squibb’s cancer drug Revlimid (lenalidomide). 8 September 2022
Generics
The retiring Roger Scarlett-Smith is to be replaced as head of UK at Germany’s STADA Arzneimittel (SAZ: Xetra) by Rudolf Bär. 6 September 2022
Generics
Indian generic drugs major Dr Reddy’s Laboratories and Aurigene Pharmaceutical Services Limited (APSL), a contract research, development and manufacturing services organization and fully owned stepdown subsidiary of Dr Reddy's, announced a Memorandum of Understanding (MoU) with the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development body that develops new therapeutic solutions for neglected diseases and the DNDi India Foundation. 2 September 2022
Generics
It was not so very long ago that Indian drugmakers were facing headwinds due to the spike in prices of active pharmaceutical ingredients (APIs) and intermediates being imported from China. From being dependent on China for APIs in the past, India has now swung to the opposite end of the spectrum and is imposing anti-dumping duties on several APIs and key starting materials that come from China, reports The Pharma Letter’s India correspondent. 30 August 2022
Generics
STADA Arzneimittel showed persistence in a challenging operating environment marked by macroeconomic and geopolitical uncertainties to report double-digit sales and earnings growth in the first half of 2022, the German drugmaker reported today. 25 August 2022
Generics
AMPAC Fine Chemicals (AFC), an SK pharmteco company, has opened its new Complex Molecule Chemistry & Engineering Center in Rancho Cordova, California. 24 August 2022
Generics
Russia plans to rebuild its pharmaceutical sector, which has been hit significantly by international sanctions and their consequences, that will be part of the recently announced state strategy of ensuring Russia’s national drug sovereignty by reducing the country’s dependence on the imports at all stages of drug production, from intermediates to the production of pharmaceutical substances. 23 August 2022
Generics
A US federal court on Friday ordered an Illinois company to stop manufacturing and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). 22 August 2022
Generics
As generic drugmakers are dragged to court by patent holders and the cost of litigation soars for both generic as well as innovative pharma companies, many are settling patent disputes out of court. Generic companies often agree to delay their entry into the market in exchange for certain benefits, such as licenses to other patents, reports The Pharma Letter’s India correspondent. 16 August 2022
Generics
USA-based Amneal Pharmaceuticals has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for four generics products. 12 August 2022
Generics
Indian drugmaker Strides Pharma Science today announced that its formulation facility at Singapore underwent a US Food and Drug Administration (FDA) inspection that ended on August 8, 2022. 11 August 2022
Generics
Japanese drug major Chugai Pharmaceutical announced that, along with majority owner Roche and its biotech subsidiary Genentech (collectively “the companies”) have entered into a settlement agreement with Fresenius Kabi USA, on August 5, 2022 relating to the patent lawsuit filed by the companies on March 19, 2020. 9 August 2022
Generics
Shares in Sun Pharma closed more than 5% higher on Friday. 1 August 2022
Generics
The US Food and Drug Administration’s (FDA) Office of Generic Drugs has published its first progress report on the activities and accomplishments of the Global Generic Drug Affairs program’s Generic Drug Cluster. 1 August 2022
Generics
UK-based specialty pharmaceutical company CNX Therapeutics said this morning it has successfully completed the acquisition of Synchrony Pharma and its existing portfolio of commercialized products. 29 July 2022
Generics
ViiV Healthcare, the global specialist HIV company majority owned by GSK, and the Medicines Patent Pool (MPP) today announced the signing of a new voluntary licensing agreement for patents relating to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) to help enable access in least developed, low-income, lower middle-income and Sub-Saharan African countries. 28 July 2022
Generics
Shares of Israeli generics giant Teva Pharmaceutical Industries were up 14.7% at 2,856 shekels this morning, as it announced it has reached an agreement in principle with the working group of US States’ Attorneys General, counsel for Native American Tribes, and plaintiffs’ lawyers representing the States and subdivisions, on the primary financial terms of a nationwide opioids settlement. 27 July 2022
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