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Analysis and opinion covers key topic areas such as:
Generics Bulletin
By Aidan Fry 15 Aug 2019
By acquiring global rights to epinephrine and naloxone nasal spray candidates from Insys, Hikma is following its strategy of moving its non-injectable Generics business segment in the US towards differentiated products.
Topic Business strategies
Generics Bulletin
By David Wallace 14 Aug 2019
Chirag Patel and Chintu Patel have returned to being co-CEOs of Amneal, just over a year after the firm completed its merger with Impax. Rob Stewart – who was president and CEO of Amneal – and executive chairman Paul Bisaro have resigned from the roles.
Topic Company analysis
Generics Bulletin
By Aidan Fry 09 Aug 2019
With Erez Israeli set to step up from COO to CEO, Dr Reddy’s is looking to leverage its lack of debt and strong cash flow in the mergers and acquisitions arena.
Topic Business strategies
Generics Bulletin
By David Wallace 30 Jul 2019
As Sandoz reported its second-quarter financial results, the firm revealed details of a previously unannounced development program for biosimilar denosumab.
Topic Company analysis Biosimilars
Generics Bulletin
By Anju Ghangurde 26 Jul 2019
More Indian companies are headed to China, with Cipla the latest to seal a joint venture there, though the firm has previous links with the country. Respiratory products will lead Cipla’s line-up in China, a market seen as a crucial cog in the firm’s future road map.
Generics Bulletin
By Penelope MacRae 12 Jul 2019
The US FDA has slapped Biocon with a dozen observations over three units at its insulin manufacturing facility in Malaysia, but the Indian biotech firm says the problems can be remedied quickly and that US launch plans are on track for its insulin product glargine challenging French drug-maker Sanofi’s multi-billion-dollar Lantus.
Topic FDA Diabetes BioPharmaceutical
Generics Bulletin
By Penelope MacRae 05 Jul 2019
India’s Strides has received a warning letter from the US Food and Drug Administration over compliance issues at its Puducherry plant. However, the firm has told investors the regulatory action will not affect its forecast of 20% US sales growth for this financial year.
Topic FDA Policy and regulation
Generics Bulletin
02 Jul 2019
The FDA has approved Samsung Bioepis’ Eticovo as the second biosimilar competitor to Amgen’s blockbuster rheumatoid arthritis biologic Enbrel. Amgen immediately sued for patent infringement.
Topic FDA Drug review
Generics Bulletin
By Aidan Fry 22 Mar 2019
Abraxis’ attempt to obtain a UK SPC for its Abraxane formulation of the known active ingredient paclitaxel has been thwarted by the CJEU.
Topic BioPharmaceutical
Generics Bulletin
By David Wallace 07 Mar 2019
Two new categories – Value Added Medicine Of The Year and Legal Strategy Of The Year – have been added to the Global Generics & Biosimilars Awards in 2019, which will take place on 5 November in Frankfurt, Germany.
Topic BioPharmaceutical Biosimilars
Generics Bulletin
By David Wallace 07 Mar 2019
Several US senators have lent their backing to the draft Biologic Patent Transparency Act, as part of efforts to address “patent thickets” around brand biologics.
Generics Bulletin
14 Feb 2019
Alvogen is claiming the first European launch of a generic rival to Revlimid, rolling out the oncology drug in several central and eastern European markets. Meanwhile, IPR challenges to three Revlimid patents in the US have been denied.
Topic Drug review
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