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Dispatches from Interphex Japan

Tokyo drift? Large molecule R&D shortfall threat to Japanese pharma, says Chugai

28-Jun-2017 - A failure to embrace biologics R&D has restricted Japanese pharma’s global growth, says CEO of Roche subsidiary Chugai Pharmaceuticals.

Lonza’s $5.5bn Capsugel takeover cleared by regulators

27-Jun-2017 - Lonza expects to complete its $5.5bn (€5.2bn) takeover of Capsugel SA in the next few days having secured approval from competition authorities around the world.

US FDA rejects Pfizer's Epogen biosimilar citing McPherson site warning

23-Jun-2017 - Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.

EMA committee gives Samsung Bioepis nod for Humira biosimilar Imraldi

23-Jun-2017 - The EMA has recommended the approval of Samsung Bioepis’ adalimumab biosimilar, placing the firm on the brink of having three anti-TNF inhibitors in Europe.

ImmunoCellular Therapeutics halts brain cancer cell therapy trial due to lack of cash

22-Jun-2017 - ImmunoCellular Therapeutics Ltd has halted a Phase III trial of its brain cancer cell therapy ICT-107 due to a lack of funds and is looking for a buyer or partner...

Ex-PM David Cameron tells BIO 2017 not to worry about Brexit effect on employees

21-Jun-2017 - Didn’t make it to San Diego this year? Well neither did we, but still we bring you the best BIO 2017 has to offer.

Patient deaths end Seattle Genetics leukaemia Phase III trial

21-Jun-2017 - Seattle Genetics announced it has discontinued its Phase III Cascade trial of Vadastuximab Talirine (SGN-CD33A) for the treatment of frontline acute myeloid leukaemia (AML), due to patient deaths.

Wuxi Biologics IPO in Hong Kong brings in $511m

16-Jun-2017 - Wuxi Biologics (Cayman) Inc. completed a successful IPO on the Hong Kong stock exchange on Tuesday, raising $511m.

The World Bank invests in Indian Biopharma

16-Jun-2017 - The Indian government has announced a $250m investment in the development of biopharmaceuticals and medical devices to address public health concerns.

Merck & Co pauses two Ph III Keytruda studies after patient deaths

14-Jun-2017 - Merck & Co has halted two Phase III studies examining its drug Keytruda (pembrolizumab) in combination with other therapies after reports of patient deaths.

Roche accused of charging too much for Herceptin in South Africa

13-Jun-2017 - Roche has been accused of charging too much for its breast cancer drug trastuzumab by South African competition authorities.

Lonza plugs EU cell and gene therapy manufacturing gap through PharmaCell buy

09-Jun-2017 - The acquisition of Dutch commercial cell and gene therapy maker PharmaCell places Lonza as the leading CDMO in the space, the firm says.

CEO scouts top E&W Coast scientific talent to secure Merck & Co.'s future

‘Don’t underestimate Merck's vaccine business,’ says CEO

07-Jun-2017 - CEO Ken Frazier has told investors investments and partnerships, such as collaboration with messenger RNA firm Moderna Therapeutics, have bolstered Merck & Co.’s vaccine division.

Approval for biomarker-based Keytruda a US FDA first

01-Jun-2017 - US FDA has approved a cancer treatment based on a common biomarker, as opposed to the location in the body where the tumour developed.

J&J confident of retaining Remicade rewards as biosimilar clouds gather

31-May-2017 - Bestselling biologic Remicade (infliximab) will remain a multi-billion dollar product for J&J for at least the next five years, even with biosimilar competition the firm says.

40 in, 200 out: Novartis hires and fires in New Jersey

30-May-2017 - Swiss-headquartered Novartis Pharmaceuticals plans to add 40 positions to its manufacturing facility in Morris Plains, New Jersey, to focus on cell therapies.

Second time the charm for Pfizer’s Epogen biosimilar in US

30-May-2017 - An advisory committee has recommended approval of Retacrit in the US after Pfizer addressed manufacturing and clinical concerns from its first submission in 2015.

Aduro and Merck & Co to test Keytruda and CRS-207 in second cancer study

22-May-2017 - Merck & Co and Aduro Biotech have announced plans to test Keytruda combined with CRS-207 in patients suffering malignant pleural mesothelioma as a result of exposure to asbestos.

Novartis in Switzerland: Biologics job boost but 500 'traditional' jobs to go

19-May-2017 - Novartis will add around 350 Swiss jobs to support its innovative biologics pipeline as it looks to cut 500 more “traditional” development and manufacturing roles.

Thermo Fisher: $7.2bn Patheon sits in sweet spot for bioproduction business

17-May-2017 - Thermo Fisher says Patheon will become the most competitive biologics CDMO in the market through direct access to its bioprocessing technologies and capabalities.

Boehringer Ingelheim opens Shanghai contract biomanufacturing plant

16-May-2017 - Boehringer Ingelheim says the biologics plant it opened in Shanghai, China today will cater for customers targeting local and international markets.

Consolidated vaccine sector urgently needs a workforce booster shot, Sanofi

16-May-2017 - Long life-cycles and significant consolidation in the manufacturing space have led to a lack of skilled workers in the vaccine space, says Sanofi Pasteur.

Seven-year switch? Formycon bets on third wave biosimilars with Stelara candidate

12-May-2017 - Formycon says it is aiming to bring the first biosimilar of J&J’s immunology best-seller Stelara (ustekinumab) to market as early as 2023 in the US.

Irish ayes: Lilly goes ahead with bioproduction expansion, adding 130 jobs

10-May-2017 - Eli Lilly has confirmed it will build a three-story biomanufacturing facility at its site in Kinsale three months after rumours the project had been put on hold.

Biosimilars in Europe: 11 years, 28 approvals, 0 safety concerns

10-May-2017 - The EMA has not experienced any concerns with the safety of the 28 biosimilar products it has recommended, according to an information guide published for healthcare professionals.

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