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
Israel-based Teva Pharmaceutical Industries says it has received US Food and Drug Administration approval of the generic equivalent to Lovaza (omega-3-acid ethyl esters capsules, USP). 8 April 2014
In a joint letter sent to the European Commission and the Office of the US Trade Representative, the USA’s Generic Pharmaceutical Association (GPhA) and European Generic medicines Association (EGA) recommended that Transatlantic Trade and Investment Partnership (TTIP) negotiators pursue a strategy of regulatory convergence. The letter focuses on specific ways that trade agreements can remove duplicative processes. 8 April 2014
In something of a surprise announcement, Sun Pharmaceutical Industries revealed this morning that it has entered into a definitive agreement to acquire fellow Indian drugmaker Ranbaxy Laboratories in an all-stock transaction. 7 April 2014
Indian generic companies are taking aim at mega blockbusters, and AstraZeneca, the $25.7 billion pharmaceutical giant, is girding itself for heated competition on two of its best-selling drugs, Nexium (esomeprazole) and Pulmicort (budesonide), before the patents on these drugs expire. 6 April 2014
After a day of rumor and speculation about a takeover approach from US generic firm Mylan, Swedish drugmaker Meda issued a statement confirming that it has been contacted by Mylan regarding an indicative proposal to combine the two businesses. 6 April 2014
Ireland-headquartered generics major Actavis has officially opened its new regional office in Singapore that will serve as the headquarters for the company's Asia Pacific and Africa region and drive growth in these emerging markets. 3 April 2014
Pamplona Capital Management has as acquired a majority stake in privately-held US company Alvogen, which it says is one of the fastest growing generics companies in the pharmaceutical industry. 2 April 2014
Hikma Pharmaceuticals, Jordan's largest pharmaceutical company, has received a close-out letter from the US Food and Drug Administration that lifts the warning letter received in February 2012 in respect of its Eatontown facility in New Jersey, which provides oral products for the US market. 2 April 2014
European Generic Medicines Association (EGA) revealed this morning that its president, Nick Haggar, has presented the trade group’s priorities for European Union Trade Policy to EU Commissioner Karl De Gucht. 2 April 2014
Ireland-headquartered US generic major Actavis has acquired Silom Medical Company, a privately held generic pharmaceutical firm focused on developing and marketing therapies in Thailand, for around $100 million in cash. 2 April 2014
Privately-held US generics firm Prasco has signed a further deal with US pharma major Eli Lilly to market the authorized version of the latter’s osteoporosis drug Evista (raloxifene), in 60mg strength in the USA. 1 April 2014
US generics major Actavis says that the US Court of Appeals for the Federal Circuit has reversed a lower court ruling that Actavis' generic version of Ireland-headquartered Shire's Lialda (mesalamine extended-release tablets) infringes US Patent No 6773,720 (the '720 Patent). 31 March 2014
Brazil is failing to produce the number of active pharmaceutical ingredients in order to produce the drugs it needs, writes Juliane Carvalho of Brazil Pharma News. 28 March 2014
The size of the Philippine pharmaceutical market, now worth around $3.2 billion, is expected to expand rapidly following the government’s enactment of universal health care coverage in 2013. 28 March 2014
A medicine that combines tenofovir (Gilead’s Viread) and lamivudine (GlaxoSmithKline’s Combivir) used to treat patients with HIV/AIDS is expected to be distributed through Brazil's Unified Health system (SUS) by the end of this month, writes Juliane Carvalho on Brazil Pharma News. 27 March 2014
US generics major Mylan reveals that, after a trial in the US District Court for the District of New Jersey, a jury returned a verdict in favor of Mylan in its breach of contract law suit against UK pharma giant GlaxoSmithKline relating to paroxetine hydrochloride extended-release tablets, the latter’s once blockbuster antidepressant Paxil. 27 March 2014
US generics major Actavis and Canada’s Valeant Pharmaceuticals said that the US Food and Drug Administration has approved the New Drug Application for Metronidazole 1.3% Vaginal Gel, an antibiotic for the treatment of bacterial vaginosis. 26 March 2014
German generic and branded drugmaker Stada Arzneimittel posted a solid set of financial results for 2013, but saw its shares plunge 15% to 29.40 euros by close of trading yesterday, as the company warned of a poor outlook as a result of uncertainties in Russia and Ukraine. 25 March 2014
US generics major Mylan says the US District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist (formoterol fumarate) Inhalation Solution. 25 March 2014
Members of the generic medicines industry sector in Australia say they welcome the release by IP Australia of the government’s Pharmaceutical Patent Review. 25 March 2014
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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.