Following an inspection from the US medicines regulator, a manufacturing site run by Indian active pharmaceutical ingredient (API) specialist Aparna Pharmaceuticals has received a VAI classification. 12 February 2024
The share of cheap drugs in the Russian pharmaceutical market is steadily declining, while in the last three years their overall range in the market has declined two-fold, reports The Pharma Letter’s local correspondent. 7 February 2024
The Russian drugmaker Axelpharm is demanding a compulsory license for an antitumor drug based on Bosulif (bosutinib), marketed by US pharma giant Pfizer, reports The Pharma Letter’s local correspondent. 6 February 2024
India’s largest drugmaker Sun Pharmaceutical Industries has reported a strong set of financials for the fiscal year 2024 quarter ending December 31, 2023. 5 February 2024
In a bid to focus on growth and innovation, Israeli generics drugmaker Teva Pharmaceutical is to hive off its active pharmaceutical ingredient (API) business. 1 February 2024
Drugmakers from China and India have been unable to replace clinical trials on original drugs from Western manufacturers on the Russian market after February, 24 2022, The Pharma Letter’s local correspondent reports. 29 January 2024
Yesterday, the US Food and Drug Administration (FDA) published the following guidances for Abbreviated New Drug Applications (ANDAs) for the generic medicines industry: 25 January 2024
Hong Kong-based Uni-Bio Science has secured approval from the China National Medical Products Administration (NMPA) for Bogutai (teriparatide), a treatment for osteoporosis. 22 January 2024
Sun Pharmaceutical Industries of India announced its intention to acquire all outstanding shares of US generics drugmaker Taro Pharmaceutical Industries at a price of $43 per share in cash, the companies announced. 19 January 2024
Switzerland’s medicines regulator, Swissmedic, has updated its guidance regarding the authorization of generic medicines with certain active pharmaceutical ingredients (API). 16 January 2024
Vyacheslav Kokeladze, a well-known Russian businessman and pharmaceutical tycoon, is investing about 1.4 billion roubles ($20 million) in the establishment of one of the country’s largest production facilities for generic medicines. 16 January 2024
Russia plans to revise the main concepts of public procurements of anti-tuberculosis drugs in a move to switch on the purchases of more efficient drugs with lower cost and side effects, The Pharma Letter’s local correspondent reports. 15 January 2024
A generics drugmaker has had its Abbreviated New Drug Application for the radiopharmaceutical 177Lu-PNT2003 accepted by the US Food and Drug Administration. 12 January 2024
A high-level committee, established to spearhead India's drive towards self-sufficiency in bulk drugs, has raised concerns about the substantial underutilization of allocated funds. 9 January 2024
Brazil’s Institute of Drug Technology (Farmanguinhos/Fiocruz) has signed a technology transfer agreement for the production of the medicine tofacitinib citrate, a generic clone of US pharma giant Pfizer’s Xeljanz. 8 January 2024
India's aspiration for pharmaceutical self-reliance hit a rough patch as recent data indicates a surge in imports of bulk drugs and intermediates from various countries, including China, over the past two years. 28 December 2023
The US Food and Drug Administration (FDA) published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). 20 December 2023
US biotech major Biogen today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of the company’s multiple sclerosis therapy, Tecfidera (dimethyl fumarate). 19 December 2023
Protek, one of Russia's leading pharmaceutical distributors, will begin the supplies of an Ozempic (semaglutide) generic, originated by Danish diabetes care and obesity giant Novo Nordisk against diabetes mellitus to the Russian market by the end of this year, reports The Pharma Letter’s local correspondent. 12 December 2023
Russia is experiencing a sharp growth in the demand for drugs against diabetes this year, particular those that are also used for weight loss, reports The Pharma Letter’s local correspondent. 4 February 2025
US President Donald Trump has implemented a series of tariffs on imports from Canada, Mexico and China, but the additional taxes could affect the price Americans pay for generic drugs, with pharma trade groups expressing their fears about the consequences. 4 February 2025
Russia plans to significantly expand the geography of the export of its drugs this year, paying attention both to emerging nations and developed countries, reports The Pharma Letter’s local correspondent. 3 February 2025
Swiss generic and biosimilars drugmaker Sandoz today revealed that Francisco Ballester, president Region International and a member of the Sandoz executive committee, will retire and step down from the SEC on March 1, 2025. 3 February 2025
This article explores the latest conversations around generic topical and transdermal drug delivery systems (TDS) in the US Food and Drug Administration’s (FDA dermal pharmacology space, delving into recent guidance updates and examining the challenges facing the development of generic TDS. 21 January 2025
Several of the USA’s biggest pharmacy benefit managers (PBMs) have generated billions of dollars in revenue by charging “enormous mark-ups,” according to the competition regulator. 15 January 2025
Swiss pharma giant Novartis has expressed its satisfaction at a decision by the US Court of Appeals for the Federal Circuit (CAFC) that affirms the validity of the Entresto (sacubitril/valsartan) combination patent. 14 January 2025
India's Parliamentary panel has come down heavily on the National Pharmaceutical Pricing Authority (NPPA) and directed it to provide a detailed report explaining the recent 50% price increase on 11 essential drug formulations. 30 December 2024
Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024
The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024
The US Court of Appeals for the Federal Circuit on Friday affirmed a lower district court order against Israeli pharmaceutical maker Teva Pharmaceutical Industries requiring its US subsidiary to delist several asthma inhaler patents from the Food and Drug Administration’s (FDA) Orange Book. 23 December 2024
Venture capital firm BC Partners has entered into an agreement under which the private equity business at Goldman Sachs Alternatives will acquire a majority stake in Netherlands-based Synthon, from funds advised by BC Partners. 17 December 2024
Swiss generic and biosimilar medicines major Sandoz today announced a number of steps to resolve the US Generic Drug Antitrust Class Action Litigation. 17 December 2024
Shares of Swedish pharma firm Orexo leapt 20.2% to 20.60 kronor this morning, following its announcement over the weekend that is has reached a settlement agreement with India’s Sun Pharmaceutical Industries to resolve the patent litigation regarding Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII), for the treatment of opioid use disorder in the USA. 16 December 2024
Israeli drugmaker Teva Pharmaceutical Industries has entered into an agreement with JKI - established by the fund managed and operated by J-Will - whereby all shares of Teva Takeda Pharma Limited and its wholly-owned subsidiary, Teva Takeda Yakuhin, will be transferred to JKI. 6 December 2024
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
Indian drugmaker Aurobindo Pharma has taken on the might of China in terms of Penicillin G pricing, and is doing so by leveraging a fully integrated production process at its new plant. Anticipating the price erosion of Penicillin G, the company has put up an integrated plant from scratch. 10 November 2024
Indian markets are abuzz with a singular refrain. Donald Trump's Presidency of the United States is set to open new opportunities for India, especially in the pharmaceutical sector. 8 November 2024