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.
The US Food and Drug Administration yesterday displayed a notice in the Federal Register announcing the availability of a guidance for industry, titled Acceptability of Draft Labeling to Support ANDA Approval. 6 October 2015
New Jersey-based specialty generic company IGI Laboratories say it has acquired three currently marketed injectable products from privately-held US biotech firm Concordia Pharmaceuticals for $10 million in cash. 6 October 2015
The US Food and Drug Administration has approved US generics drugmaker Impax Laboratories’ generic version of diabetes drug glyburides, marketed as Diabeta by France’s Sanofi. 5 October 2015
Family-owned German drugmaker Grünenthal Group says that its Tecnandina manufacturing plant in Ecuador has received certification from the Regulatory Authority of Brazil, ANVISA. 5 October 2015
The US Federal Trade Commission has filed an amicus brief before the US Court of Appeals for the Third Circuit explaining that the district court made significant analytical errors in ruling for defendants in a dispute involving allegations of pharmaceutical “product hopping.” 2 October 2015
US drugmaker United Therapeutics has entered into a settlement agreement with Sandoz Inc, a US generics unit of Swiss pharma giant Novartis, relating to ongoing litigation concerning certain patents relating to its Remodulin (treprostinil) Injection. 30 September 2015
Pharmaceutical companies Ireland-headquartered Endo International (Nasdaq: ENDP) and privately-held Par Pharmaceutical have agreed to divest all of Endo’s rights and assets to generic glycopyrrolate tablets and generic methimazole tablets in order to settle US Federal Trade Commission charges that the proposed $8 billion acquisition (The Pharma Letter June 18) would be anticompetitive. 28 September 2015
ANI Pharmaceuticals has agreed to acquire the New Drug Applications for purified corticotropin gel and corticotropin-zinc hydroxide from pharma giant Merck & Co. 21 September 2015
US biotech company BioMarin and Indian pharma company Dr Reddy’s have settled their patent litigation over Kuvan tablets (sapropterin). 21 September 2015
For the third time, German drugmaker Stada Arzneimittel invited investors and analysts to a Capital Markets Day. This year, the focus of the event was on Stada's engagement in Russia. 18 September 2015
CPhI Worldwide, organized by UBM EMEA, launches part i of its annual report ahead of CPhI Worldwide 2015 in Madrid (October 13-15) – as CPhI expert Girish Malhotra calls for a radical solution to improve pharma manufacturing processes. 17 September 2015
Albany Molecular Research on Tuesday said it expects the acquisition of Gadea Pharmaceutical to add over 50% to its full year contract revenue and over 40% for adjusted per share earnings. 15 September 2015
The Indian Pharmaceutical Alliance (IPA) has dropped its opposition to Gilead’s patent application for Sovaldi (sofosbuvir), as the company has voluntarily made a licensing agreement with 11 companies to sell a lower-cost generic. 15 September 2015
Netherlands-incorporated generic drugmaker Mylan has officially initiated its hostile takeover bid for Ireland-based Perrigo, following public rejections from the management. 15 September 2015
At a press conference last week, Hartmut Retzlaff, chairman of German drugmaker Stada Arzneimittel, highlighted the strategy that the group has been pursuing under his leadership for more than 20 years. 12 September 2015
Ireland-incorporated Allergan has received US Food and Drug Administration approval for its Abbreviated New Drug Applications for three Mucinex equivalent products, a brand from Reckitt Benckiser. 11 September 2015
Netherlands-incorporated generic drugmaker Mylan said it will launch a $27.1 billion hostile takeover bid for the Ireland-based company Perrigo. 9 September 2015
Netherlands-incorporated Mylan today announced the US launch of drospirenone and ethinyl estradiol tablets USP, 3 mg/0.03 mg, which is the generic version of German pharma major Bayer's Yasmin Tablets 8 September 2015
The pharmaceuticals manufacturing industry in India is expected to be worth $41.92 billion by 2020, expanding at a compound annual growth rate (CAGR) of 19.76% from 2015 to 2020. 8 September 2015
Indian drugmaker Cipla has entered into definitive agreements to acquire two USA-based companies, InvaGen Pharmaceuticals and Exelan Pharmaceutics. 4 September 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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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.