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.
Medicines regulator Health Canada has requested that Canadian importers voluntarily quarantine drug products with active pharmaceutical ingredients (APIs) manufactured or tested by Polydrug Laboratories, in Ambarnath, Maharashtra, India, due to data integrity concerns. 25 June 2015
US sterile generics and biosimilars maker Hospira says its Indian subsidiary has received official notification from the US Food and Drug Administration that the inspection of the Visakhapatnam, India facility (the “Vizag facility”) was deemed acceptable for the manufacture of finished dosage drugs. 25 June 2015
Japanese drug major Daiichi Sankyo has entered into a collaboration with fellow Japan-based Maruishi Pharmaceutical to commercialize the general anesthesia analgesic, remifentanil injection generic. 24 June 2015
The USA’s Federal Trade Commission last week filed an amicus brief in the US Court of Appeals for the First Circuit urging the court to reject a district court decision in a reverse-payment patent settlement case. 22 June 2015
Over 2,000 brands of common medicines could be slashed in price for millions of Australians – some by as much as 50% – from next year in a “win-win” for consumers and taxpayers, the government announced yesterday. 22 June 2015
ScinoPharm Taiwan and Chinese company Raffles PharmaTech are to collaborate on the manufacture of celecoxib, a non-steroidal and anti-inflammatory analgesic active pharmaceutical ingredient. 22 June 2015
A consortium of investors led by CVC Capital Partners and including Singapore-based investment company Temasek and Vatera Healthcare Partners have acquired a controlling stake in USA-based generic drugmaker Alvogen. 22 June 2015
Japanese drug major Daiichi Sankyo has announced that its generics subsidiary, Daiichi Sankyo Espha, will launch seven new generic drugs with four new active ingredients. 19 June 2015
Sandoz, the generics unit of Swiss drug major Novartis, yesterday announced the US launch of Glatopa, the first generic version of Teva Pharmaceutical Industries’ Copaxone. 19 June 2015
The US Court of Appeals for the Federal Circuit has again found that US Patent No 5,800,808, related to a method of manufacturing glatiramer acetate, the active ingredient of Israel-based Teva Pharmaceutical Industries blockbuster multiple sclerosis drug Copaxone, is invalid as indefinite. 18 June 2015
Regulatory agency Health Canada is restricting the importation of drugs from manufacturing facilities operated by US injectable drugs and infusion technologies and biosimilars developer Hospira in Liscate, Italy, due to data integrity concerns. 18 June 2015
In a statement by Ralph Neas, president and chief executive of the US trade group the Generic Pharmaceutical Association (GPhA), he welcomed the opportunity that has been provided to discuss strengthening the Food and Drug Administration’s implementation of the Generic Drug User Fee Act (GDUFA). 16 June 2015
United Therapeutics says it has received a Paragraph IV Certification Notice Letter from Watson Laboratories, advising that it has submitted an Abbreviated New Drug Application to the US Food and Drug Administration requesting approval to market a generic version of Tyvaso (treprostinil) Inhalation Solution. 15 June 2015
The European Generic and Biosimilar medicines Association (EGA) last week launched the European Value Added medicines (EVA) group, a new sector group of the EGA. 15 June 2015
US Generics Pharmaceutical Association (GPhA) president and chief executive Ralph Neas has expressed concerns about what he sees as a negative impact of the proposed Trans-Pacific Partnership (TPP) between the USA, Japan and 10 other countries. 13 June 2015
Germany-based generic drugmaker Stada Arzneimittel’s Serbian subsidiary Hemofarm recently celebrated the opening of a state-of-the-art production and filling facility for ampoules in Vršac. 12 June 2015
Cardinal Health says it plans to acquire The Harvard Drug Group (THDG), a distributor of generic pharmaceuticals, over-the-counter medications and related products to retail, institutional and alternate care customers. 8 June 2015
Generics major Mylan has launched the first bioequivalent to Seretide Evohaler (salmeterol xinafoate/fluticasone propionate) from GlaxoSmithKline. 8 June 2015
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
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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.