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28 January 2025 The headline payment percentage for newer medicines under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) has been set at 22.9% for 2025, raising concerns from the UK pharma industry.
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Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Generics
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
Generics
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
Generics
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
Generics
US generic drugmaker Viatris announced robust financial results for the third quarter of 2024, driven by positive momentum against all three pillars of its strategy. The company’s shares shot up 13.5% to $13.18 following the announcement. 8 November 2024
Generics
Teva Pharmaceutical Industries’ shares were up 4% at 7,323 shekels today reported results for the quarter ended September 30, 2024. 6 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Generics
Swiss biosimilars and generics group Sandoz today reported net sales for the third quarter ended September 30, 2024. 30 October 2024
Generics
Lexicon Pharmaceuticals announced that Viatris has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the USA and Europe in all indications. 18 October 2024
All news
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
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
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Generics
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
Generics
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
Generics
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
Generics
US generic drugmaker Viatris announced robust financial results for the third quarter of 2024, driven by positive momentum against all three pillars of its strategy. The company’s shares shot up 13.5% to $13.18 following the announcement. 8 November 2024
Generics
Teva Pharmaceutical Industries’ shares were up 4% at 7,323 shekels today reported results for the quarter ended September 30, 2024. 6 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Generics
Swiss biosimilars and generics group Sandoz today reported net sales for the third quarter ended September 30, 2024. 30 October 2024
Generics
Lexicon Pharmaceuticals announced that Viatris has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the USA and Europe in all indications. 18 October 2024
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