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 international investors and fund managers have expressed an interest in investing in the Indian pharmaceutical and biotechnology sectors, underlining the need to establish a platform to facilitate the transition of global capital flows into the domestic economy. 14 April 2023
The Russian government plans to take additional measures to further increase the share of domestic drugs in the local market, as pressure from the West on the country and its pharmaceutical sector is growing. 7 April 2023
The expiration of the patent for palbociclib, a leading anti-breast cancer drug, in India has opened up new opportunities for generic versions of the drug. The Indian government highlighted this development in Parliament and intensely discussed the endless possibilities that could arise from the availability of generic palbociclib and other similar generic oncology drugs, reports The Pharma Letter’s India correspondent. 30 March 2023
After announcing the start of discussions early last year relating to its cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP), ViiV Healthcare, which is majority-owned by UK pharma major GSK, says an accord has now been struck with the Medicines Patent Pool (MPP). 30 March 2023
Russia will allow domestic drugmakers to develop generics of original foreign drugs under patent protection only in case of exodus of their producers from the Russian market. 29 March 2023
Even as the World Trade Organization (WTO) members continue to remain divided on the waiver of intellectual property (IP) rights for Covid-related vaccine technologies, India, South Africa, and other developing countries have resuscitated their campaign to extend the temporary waiver of IP for Covid vaccines to coronavirus drugs at the WTO. 22 March 2023
Zydus Lifesciences today revealed it has received final approval for Tofacitinib Tablets, 5mg and tentative approval for Tofacitinib Tablets, 10mg, generic versions of US pharma giant Pfizer’s Xeljanz from the US Food and Drug Administration (FDA). 21 March 2023
Zeta Pharma is a fast-growing branded generic pharmaceutical company in the Egyptian market that was established in 2010 and started its production and marketing activities in 2015 on the hepatitis C virus products products Sofocivir, Zetaciver and Sofocivir Plus. 10 March 2023
Original drugs have begun to be massively replaced by generics in the Russian pharmaceutical market, which is mainly due to falling real incomes of local customers and the overall negative situation in the country’s economy, reports The Pharma Letter’s local correspondent. 7 March 2023
German generics drugmaker STADA Arzneimittel has reported 11% growth in sales in its annual results statement, propelled by “numerous launches and line extensions, market-share gains and strong supply reliability.” 6 March 2023
Taiwan generics drugmaker Lotus Pharmaceuticals has received approval in Vietnam for its cancer drug vinorelbine soft gel in two varieties - 20mg and 80mg- to compete with the branded version Navelbine, originated by French drugmaker Pierre Fabre. 3 March 2023
In 2022, generic drugs remained a significant public health priority for the US Food and Drug Administration (FDA), the agency announced yesterday, along with publishing its 2022 Office of Generic Drugs (OGD) Annual Report. 2 March 2023
US generic drug-focussed drugmaker Viatris has announced that, as it prepares to enter Phase 2 of its previously revealed strategic plan in 2024, the appointment of pharma veteran Scott Smith to lead the execution of that plan as Viatris' new chief executive (CEO), effective April 1, 2023. 28 February 2023
Indian generic drug major Dr Reddy's Laboratories saw its shares dip 1.2% to 4,411 rupees, as it revealed it has entered into a definitive agreement to acquire the US generic prescription product portfolio of Australia-based Mayne Pharma. 27 February 2023
Four applicants have received the first tranche of incentives under India's Production Linked Incentive (PLI) scheme released by the Department of Pharmaceuticals (DoP), which awarded the Indian drugmakers $20 million. 23 February 2023
Patients in India suffering from cystic fibrosis are petitioning the Indian government to allow generic versions of Vertex Pharmaceuticals’ (Nasdaq: VRTX) Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) and Orkambi (lumacaftor/ivacaftor). 17 February 2023
Indian drugmaker Glenmark Pharmaceuticals (BSE: 532296) and US pharma giant Merck & Co (NYSE: MRK) are facing an antitrust lawsuit over allegations that the duo illegally settled a patent dispute in order to delay the launch of generic versions of the blockbuster cholesterol reducer Zetia (ezetimibe). 16 February 2023
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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.