6 February 2025 The 90 million euros ($94 million) raised by Orbis Medicines in a series A round was not January’s biggest venture investment by a long stretch. That honor belonged to the whopping $410 million netted by UK obesity group Verdiva Bio, but what Orbis’s VC round does show is the growing interest in macrocyclics as a drug class.
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
India’s Biocon has signed a partnership agreement with Canadian specialty pharma company Juno Pharmaceuticals, for the commercialization of its vertically integrated, complex formulation, liraglutide, a drug-device combination for the treatment and management of type 2 diabetes and obesity. 9 October 2023
On Friday, the US Food and Drug Administration (FDA) announced a revised Manual of Policies and Procedures (MAPP 5241.3), “Good ANDA Assessment Practices.” 9 October 2023
US healthcare giant Johnson & Johnson has confirmed it will not enforce its patents for the multidrug-resistant tuberculosis med Sirturo (bedaquiline) in certain lower-income countries. 3 October 2023
The US Food and Drug Administration has revised its Manual of Policies and Procedures (MAPP), in relation to suitability petitions for generic drug regulatory submissions. 3 October 2023
A report from industry analyst GlobalData finds that a range of new generic products in idiopathic pulmonary fibrosis (IPF) will likely shake up the market in coming years. 27 September 2023
The inaugural report from the Access to Medicine Foundation's Generic and Biosimilar Medicines Program has taken a look at what five major industry players are doing to expand access to their products in low- and middle-income countries (LMICs). 26 September 2023
India's Department of Pharmaceuticals is seeking innovative technologies to reduce the cost of producing Active Pharmaceutical Ingredients (APIs) that are currently imported. 26 September 2023
Indian drugmaker Glenmark Pharmaceuticals has entered into a definitive agreement with Nirma Limited to divest a 75% stake in its subsidiary, Glenmark Life Sciences Limited (GLS), which focuses on producing active pharmaceutical ingredients (APIs). 22 September 2023
In September 2022, the US President re-authorized the Generic Drug User Fee Amendments (GDUFA). This new iteration is known as GDUFA III and takes effect from October 2022 to September 2027.1 21 September 2023
Pharmasyntez, one of Russia’s leading drugmakers, is preparing a new project in the domestic market, which involves commercial production of dialysis drugs, reports The Pharma Letter’s local correspondent. 19 September 2023
Shares of Hyderabad, India-headquartered Suven Pharmaceuticals hit a fresh 52-week high on the bourses after the Indian government gave the green signal to foreign direct investment (FDI) of up to $1.15 billion by drug major Cyprus-based Berhyanda. 19 September 2023
Following scrutiny from Democratic senators in Congress, the US Federal Trade Commission has issued a policy statement on the proper listing of pharmaceutical patents. 18 September 2023
Russia is still experiencing a shortage of active ingredients for its pharmaceutical sector due to a low interest of local producers in the establishment of their own production, despite the support that has been provided to the industry by the state in recent years, reports The Pharma Letter’s local correspondent. 12 September 2023
Russian drugmaker Geropharm once again failed to challenge the patent for Toujeo (long-acting insulin glargine) produced by the French pharma major Sanofi, reports The Pharma Letter’s local correspondent. 5 September 2023
Indian generic drugmaker Strides Pharma Science announced that its stepdown wholly-owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for mycophenolate mofetil for oral suspension USP, 200mg/mL, from the US Food and Drug Administration (FDA). 4 September 2023
The US Food and Drug Administration (FDA) on Friday announced a draft guidance for industry, “Post-Warning Letter Meetings Under GDUFA.” 2 September 2023
In a major reprieve, India's National Medical Commission (NMC) has put on hold with immediate effect its recent regulation mandating doctors to prescribe only generic drugs or face strict punishment. 30 August 2023
Russian drugmaker R-Pharm is considering acquiring the manufacturing facility of Japanese pharma giant Takeda located in Yaroslavl, Russia, The Pharma Letters local correspondent reports. 30 August 2023