3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
US antivirals giant Gilead Sciences today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six generic drugmakers to make and sell generic lenacapavir 2 October 2024
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter’s local correspondent. 30 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
German generics major STADA Arzneimittel today announced that it achieved sales of more than 2 billion euros ($2.23 billion) in the first half of 2024. 28 August 2024
In a major crackdown, the Indian government has imposed an immediate ban on 156 fixed-dose combination (FDC) drugs, including commonly used antibiotics, pain relievers,and multivitamins. 27 August 2024
Swipha, a leading Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organization (WHO) for its sulfadoxine-pyrimethamine (SP) drug. 21 August 2024
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
Imports of bulk drugs from China have jumped, potentially undermining India's efforts to boost domestic pharmaceutical manufacturing through its Production Linked Incentive (PLI) scheme. 5 August 2024
Orexigen Therapeutics and partner, Japan’s Takeda Pharma have filed a law suit in the US District Court for the District of Delaware against generics major Actavis. 6 June 2015
Israel-headquartered generics giant Teva Pharmaceutical Industries had a busy day yesterday, when it announced the launch of two products in the USA. 3 June 2015
Sanbao Ghana Pharmaceuticals, a Chinese manufacturing firm in Ghana, has invested a total of $15 million to expand its production capacity, reports the Chinese state agency Xinhua. 2 June 2015
The US Federal Trade Commission has reached a settlement resolving its antitrust suit charging Cephalon with illegally blocking generic competition to its blockbuster sleep-disorder drug Provigil (modafinil). 29 May 2015
Popular generic drugs had substantial price increases between 2006 and 2013, with some prices going up as much as 1,000%, according to a new Rx Price Watch Report from AARP Public Policy Institute (PPI). 28 May 2015
The US Court of Appeals for the Federal Circuit has upheld the District Court of Delaware’s earlier ruling on Par Pharmaceuticals’ generic of Exelon (rivastigmine transdermal system), manufactured by Novartis. 27 May 2015
ViiV Healthcare, Aurobindo Pharma and the Clinton Health Access Initiative Inc (CHAI) announced today that Aurobindo Pharma has submitted an Abbreviated New Drug Application for dolutegravir 50mg to the Food and Drug Administration for the treatment of HIV. 26 May 2015
The Indian government's plan to open around 5,000 low-cost medical stores and pharmacies across the country appears to have been given a fresh lease of life, with a pilot scheme set to relaunch the sale of cheap, and in some cases free, generic drugs across six states, reports The Pharma Letter’s India correspondent. 26 May 2015
Indian drugmaker Cadila Healthcare is nearing a deal to buy the generic sterile injectables business of rival Claris Lifesciences, according to sources close to the matter. 22 May 2015
Strides Arcolab has signed definitive agreements with certain wholly-owned subsidiaries of South Africa’s Aspen Pharmacare to acquire a generic pharmaceutical business in Australia together with certain branded pharma assets. 21 May 2015
US drugmaker Lannett Company has signed a definitive agreement to acquire privately held Silarx Pharmaceuticals and a related real estate entity, a manufacturer and marketer of liquid generic pharmaceutical products. 18 May 2015
Sandoz, the generic division of Swiss pharma giant Novartis has opened the new Sandoz Packaging Centre in Stryków, Poland, a project valued at 171 million zloty ($48.3 million). 18 May 2015
Ireland-headquartered Endo International has entered into a definitive agreement under to acquire privately-held Par Pharmaceutical from private investment firm TPG in a transaction valued at around $8.05 billion, including assumption of Par debt. 18 May 2015
Indian drugmaker Lupin said today that it has acquired a100% equity stake in Brazil-based pharma company Medquímica Indústria Farmacêutica, subject to certain closing conditions. 14 May 2015
Jordanian drugmaker Hikma Pharmaceuticals (LSE: HIK) says it has made a good start to the year and reiterates its guidance for 2015 for the group overall and for each of its business segments. 14 May 2015
US drugmaker Endo International has acquired a broad portfolio of branded and generic injectable and established products from a subsidiary of South Africa’s leading pharma company Aspen Holdings. 11 May 2015
Ireland-incorporated generics giant Actavis has reported strong first-quarter 2015 financials, but posted a loss as a results of acquisition (notably Allergan) and other costs. 11 May 2015
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A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.