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Scrip: 世界の医療用医薬品＆製薬産業に関するニュース, Pink Sheet: 世界の薬事規制と承認審査に関するニ...

Mega Mergers

30 Sep 2019

When it comes to M&A, Informa Pharma Insights has got it covered. Our readers benefit from exclusive executive interviews with industry leaders and expert analysts on business, pipeline and M&A strategy, broad and detailed coverage on implications of deal-making from antitrust to quality compliance, commercial and R&D infrastructure, regional repercussions and the impact on existing partners. 2019 has already been notable for major deals, from the closing of the $62bn Takeda/Shire acquisition to the agreed purchases of Celgene for $74bn by Bristol-Myers Squibb and of Allergan for $63bn by AbbVie, to Pfizer’s plan to merge its Upjohn generics business with Mylan.

Topic business-strategies

Topic business-strategies

Topic business-strategies

Generics Bulletin: ジェネリック＆バイオシミラーニュース

Hikma Snaps Up Insys Sprays As Part Of US Drive Towards Differentiation

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: ジェネリック＆バイオシミラーニュース

Chirag Patel And Chintu Patel Return As Co-CEOs Of Amneal

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: ジェネリック＆バイオシミラーニュース

Reddy's Will Look For Acquisitions Under New CEO Israeli

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: ジェネリック＆バイオシミラーニュース

Sandoz Reveals Biosimilar Denosumab Program

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: ジェネリック＆バイオシミラーニュース

Cipla Docks Into China With Manufacturing Plans In Tow

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.

Topic company-analysis policy-and-regulation

Generics Bulletin: ジェネリック＆バイオシミラーニュース

Biocon’s Malaysia Insulin Facility Hit With 12 FDA Observations

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: ジェネリック＆バイオシミラーニュース

Strides’ Puducherry Plant Gets FDA Warning Letter

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: ジェネリック＆バイオシミラーニュース

Samsung Bioepis’ Etanercept Nod Prompts US Lawsuit

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: ジェネリック＆バイオシミラーニュース

New Formulations Of Old Ingredients Do Not Qualify For SPCs

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: ジェネリック＆バイオシミラーニュース

Two New Categories Join GGB Awards In 2019

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: ジェネリック＆バイオシミラーニュース

US Bill Aims To Increase Transparency On Biologics

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.

Topic BioPharmaceutical Drug approval Drug review

Generics Bulletin: ジェネリック＆バイオシミラーニュース

Alvogen Claims Lead On Lenalidomide In Europe

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