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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
The US Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion). 3 February 2022
Generics
Texas, USA-based Mark Cuban Cost Plus Drug Company (MCCPDC) officially launched its online pharmacy yesterday. The launch comes just weeks after its pharmacy benefit manager (PBM) operation was established - both critical efforts in the company's pursuit to help shield consumers from inflated drug prices. 28 January 2022
Generics
India's domestic drug firms with active pharmaceutical ingredient (API) assets appear to be attracting interest. A case in point is Mumbai-based generic drugs manufacturer BDR Pharmaceuticals. 25 January 2022
Generics
USA-based generic drugmaker ANI Pharmaceuticals today announced the US commercial availability of Purified Cortrophin Gel (repository corticotropin injection USP). 24 January 2022
Generics
Generic medicines in India have received a new impetus with both Prime Minister Narendra Modi and Venkaiah Naidu, Vice President of India, calling on the domestic pharmaceutical industry to work towards making India an international capital of generic drugs. 24 January 2022
Generics
London-listed Jordanian drugmaker Hikma Pharmaceuticals has agreed to acquire the Canadian assets of Teligent for $45.75 million. The transaction is expected to be completed before the end of the first quarter of 2022. 17 January 2022
Generics
London-listed Jordanian drugmaker Hikma Pharmaceuticals has launched a new outsourced sterile compounding business, called Hikma 503B. 10 January 2022
Generics
China’s Pharmaron Beijing has acquired Aesica Pharmaceuticals (the Cramlington Site) from Swedish Contract Development and Manufacturing Organization (CDMO) Recipharm group. 10 January 2022
Generics
Bangladeshi generics and active ingredients maker Beximco Pharmaceuticals today announced the launch of the world's first generic version of Pfizer’s COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir tablets, co-packaged for oral use), which was granted emergency use authorization (EUA) by the US Food and Drug Administration on December 22, 2021. 30 December 2021
Generics
Swiss drugmaker Vifor Pharma and its partner American Regent, Daiichi Sankyo’s US subsidiary, today announced that they have reached settlement agreements with Mylan Laboratories, part of Viatris, the newly-formed generics power-house resulting from the merger of Mylan and Pfizer, and Sandoz, which is about to be spun out of Novartis, that resolve the patent litigation brought in response to Abbreviated New Drug Applications seeking approval by the US Food and Drug Administration to market a generic version of Injectafer (ferric carboxymaltose). 20 December 2021
Generics
Hyderabad, India-based Natco Pharma is to acquire Dash Pharmaceuticals, a front-end pharmaceutical sales, marketing and distribution entity based in New Jersey, USA, with net sales of $15 million expected for the year ending December 2021. 16 December 2021
Generics
Supply chain disruptions, quality concerns and abrupt price hikes have been some of the issues resulting from over-dependency on a single source for supplies of life-saving drugs and other key raw materials. To mitigate risks associated with over-dependency on other nations, India's Health Minister Mansukh Mandaviya says the focus is to build self-reliance and promote the domestic pharmaceutical manufacturing industry, despite the decision to shut down two pharma public sector undertakings and disinvest three others, reports The Pharma Letter’s India correspondent. 9 December 2021
Generics
India’s largest biotech firm Biocon has entered into a partnership with Tabuk Pharmaceutical Manufacturing (a fully-owned subsidiary of Astra Industrial Group), a leading pharmaceutical company in the Middle East and North Africa (MENA), to commercialize select speciality products in the Middle East. 9 December 2021
Generics
The Indian government’s second Production Linked Incentive (PLI) scheme, with around $2 billion incentives for the pharma sector, is set to benefit 55 qualified pharma companies. 3 December 2021
Generics
The key issue when prescribing generic drugs in India is quality, not price, with Indian doctors relying on the reputation of companies that have demonstrated their commitment to quality over time. A new study has found that the perceived difference in the quality of various brands of generic drugs that can be prescribed interchangeably is one of the major barriers to effective price competition in India's drug market, reports The Pharma Letter’s India correspondent. 2 December 2021
Generics
Teva launches authorized generic of Epiduo Forte Gel in USA 1 December 2021
Generics
Russia may face a new wave of shortage of drugs against coronavirus, influenza and acute respiratory viral infections (ARVIs), as the seasonal demand for them is rising, according to recent warnings by experts of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and local analysts. 30 November 2021
Generics
Privately-held Italian biopharma company Dompé Farmaceutici has announced the sale of six brands to French drugmaker Substipharm, which specializes in niche generic and mature pharmaceutical products. 25 November 2021
Generics
British specialty medicines firm Essential Pharma today announced the closing of two transactions with fellow UK-based Rosemont Pharmaceuticals. 25 November 2021
Generics
Members of the European Parliament (MEPs) yesterday put forward proposals to make medicines more affordable and boost transparency on prices and promote joint European Union public procurement. 25 November 2021
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