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
Fewer blockbusters drugs are expected to go off-patent post 2015, resulting in a scarcity of opportunities for generic companies in Asia. Hence, generic drug manufacturers in the region are looking beyond the patent cliff to focus on market expansion and improving the quality of existing drugs. 21 April 2015
The US Food and Drug Administration yesterday approved the first generic version of Israel-based Teva Pharmaceutical Industries’ Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS). 17 April 2015
Taiwan-based Sunny Pharmtech, a developer of active pharmaceutical ingredients and finished-dose drugs, has formed a strategic partnership with US generics firm Vitruvias Therapeutics to co-develop a varied portfolio of generic drugs. 16 April 2015
At the urging of US Senator Bernie Sanders and Representative Elijah Cummings, the Department of Health and Human Services’ Inspector General has agreed to investigate how sudden price hikes by generic drug makers are driving up the cost of taxpayer-supported health care. 16 April 2015
Leading Russian pharmaceutical producers plan to significantly increase their share in the domestic market of high-priced drugs, which will be through the setting up of production of analogues of some expensive imported drugs, reports The Pharma Letter’s local correspondent. 16 April 2015
US generic drugs major Mylan and certain of its subsidiaries have entered into a settlement and license agreement with US pharma giant Pfizer to settle patent litigation. 14 April 2015
Indian drugmaker Aurobindo Pharma has sold its step down subsidiary Aurobindo Pharma Australia, with operations in Australia and New Zealand, to privately-held Eris Pharmaceuticals. 14 April 2015
US specialty drugmaker Depomed has entered into a settlement agreement with Actavis in patent infringement litigation related to Actavis' Abbreviated New Drug Application seeking approval to market generic versions of Depomed's Gralise (gabapentin). 13 April 2015
The US Food and Drug Administration has confirmed receipt of the change of ownership letters that formally transfer ownership of 23 generic drug products to IDT Australia. 13 April 2015
Indian pharma company Cipla has informed the Bombay Stock Exchange that its UK subsidiary has entered into a definitive agreement to acquire a 100% stake in Duomed Produtos Farmaceuticos of Brazil. 10 April 2015
The Russian General Prosecutor Office and the Federal Antimonopoly Service (FAS) have initiated a new wave of massive checks of national pharmacies and pharmaceutical producers, which are suspected of being responsible for a significant increase of prices for their products, reports The Pharma letter’s local correspondent. 9 April 2015
US generics major Mylan today announced it has made an unsolicited $205 per share proposal to acquire Ireland-headquartered drugmaker Perrigo. 8 April 2015
US drugmaker Perrigo says it has received final approval from the US Food and Drug Administration of its Abbreviated New Drug Application for hydromorphone HCI extended-release tablets.. 8 April 2015
US generic drugmaker Mylan says it has launched norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate Tablets, (chewable), which is the generic version of Warner Chilcott's Generess Fe. 7 April 2015
Actavis confirms that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market ambrisentan tablets, a generic version of Gilead Sciences' Letairis. 7 April 2015
US drugmaker The Medicines Company says it has settled its litigation with India’s Sun Pharmaceutical Industries and certain of its subsidiaries relating to MDCO’s US patents covering the anticoagulant Angiomax (bivalirudin). 2 April 2015
The French government has launched a national action plan to promote the use of generic medicines, aiming for a saving of 350 million euros ($375 million) by 2017. 1 April 2015
Israeli generics giant Teva Pharmaceutical Industries says it has launched a generic equivalent to Exforge (amlodipine and valsartan) tablets in four different strengths, in the USA. 31 March 2015
Privately-held US generics drugmaker Amneal Pharmaceuticals and the Australian subsidiary of Actavis have signed a binding letter of intent which provides that Amneal intends to acquire substantially all of Actavis’ in-country generic pharmaceuticals business. 31 March 2015
Shares of US generic drugmaker Mylan (Nasdaq: MYL) were down 5.4% on Monday after Abbott Laboratories (NYSE: ABT) announced that it will undergo a public offering of 35,000,000 ordinary shares. 31 March 2015
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Company Spotlight
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.