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
Several pharmaceutical companies in India, including Dr Reddy's, have been trying for months to recover funds from Venezuela. The nation is not the only one giving sleepless nights to Indian pharma exporters, struggling to counter an expected drop in export growth, reports The Pharma Letter’s India correspondent. 2 June 2016
Teva Pharmaceutical Industries has been asked to provide more information on its New Drug Application for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD) by the US Food and Drug Administration. 1 June 2016
The cost of medicines in Ukraine is the lowest in Europe, but still Ukrainians cannot afford them due to low income, according to experts of Spanish non-governmental organization CivioFoundation. 31 May 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval at its May meeting. 27 May 2016
Italy-based P&R Group has signed a binding agreement to acquire 100% of the Italian pharmaceutical chemical manufacturer, Infa Group through the P&R subsidiary Olon SpA. 26 May 2016
US specialty pharma firm Egalet says it has reached an agreement with Purdue Pharma as it relates to alleged patent infringements against Egalet and product licensor Acura Pharmaceuticals for Oxaydo (oxycodone HCl, USP) tablets CII. 23 May 2016
Shanghai-based Fosun Pharma has announced an indicative offer to buy Gland Pharma, which is based in Hyderabad, India, competing against the US pharma firm Baxter, the other potential buyer. 23 May 2016
Texas-based pharma Neos Therapeutics has announced the US launch of its Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablet), an attention-deficit/hyperactivity disorder (ADHD) bioequivalent to Adderall XR (mixed amphetamine salts). 20 May 2016
ANI Pharmaceutical has signed an exclusive distribution and supply agreement with South Africa’s Aspen Pharmacare for hydroxyprogesterone caproate Injection. 18 May 2016
BioIntegrator, a member of the Russian ChemRar group of companies, announced today the successful launch in Belorussia of Nescler, a unique oral formulation of fingolimod. 16 May 2016
The assets of Israeli drugmaker Teva Pharmaceutical International in the UK, Ireland and Iceland have attracted interest from bidders including Netherlands-incorporated Mylan and Swiss pharma giant Novartis, Bloomberg reports. 16 May 2016
According to estimates from Poland-based market research group PMR, Poland will be the most rapidly developing market in the area of generics in the next five years, given its traditionally unchangeable pro-generic policy and the generally attractive nature of the market, based on its affluence and size. 16 May 2016
Israel-based generics giant Teva Pharmaceutical Industries posted first-quarter 2016 financials, indicating that it is itself facing competition for its branded copy medicines. 9 May 2016
Bangladeshi generic drugs company Beximco Pharmaceuticals (AIM: BXP) this morning reported that net sales for full-year 2015 increased to 12,965.5 million taka ($161.5 million), registering a year-on-year growth rate of 15.7%. 9 May 2016
Albany Molecular Research has signed a definitive agreement to acquire all outstanding shares of Prime European Therapeuticals, also known as "Euticals," in a transaction valued at around $358 million (315 million euros), consisting of shares of AMRI common stock, cash and a seller note. 5 May 2016
Netherlands-incorporated generics giant Mylan today announced its financial results for the first quarter of 2016, noting that total revenues of $2.19 billion, up 19% on a constant currency basis compared to the like prior year period (up 17% on a US generally-accepted accounting principles [GAAP] basis). 3 May 2016
The Russian government is considering subsidizing the production of cheap drugs, amid the fears of their disappearance from the market, according to recent statements of Arkady Dvorkovich, Russia’s Deputy Prime Minister, reports The Pharma Letter’s local correspondent. 2 May 2016
The US Food and Drug Administration on Friday approved the first generic version of Crestor (rosuvastatin calcium), a copy of Anglo-Swedish pharma major AstraZeneca’s blockbuster cholesterol drug that is facing patient expiries. 1 May 2016
The landscape of patent litigation related to Abbreviated New Drug Applications (ANDAs) submitted to the Food and Drug Administration under the Hatch-Waxman Act is reviewed by Lex Machina, a LexisNexis company, its second Hatch-Waxman/ANDA Report. 27 April 2016
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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.