Manufacturing and Production

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Darzalex receives breakthrough designation in multiple myeloma from FDA

July 26, 2016 Manufacturing and Production, Research and Development FDA, Genmab, Janssen, darzalex, multiple myeloma

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Darzalex (daratumumab) in combination with standard of …
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AbbVie and BMS partner for Rova-T, Opdivo, Yervoy cancer combo

July 26, 2016 Manufacturing and Production, Research and Development AbbVie, BMS, Yervoy, opdivo, rova-t

AbbVie and Bristol-Myers Squibb have announced that they will collaborate on a clinical trial to test some of their leading …
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CHMP issues positive opinion for Orencia Rheumatoid Arthritis treatment

July 25, 2016 Manufacturing and Production, Sales and Marketing BMS, CHMP, Orencia, rheumatoid arthritis

Bristol-Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) has released a positive opinion of …
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MHRA approves Sanofi Pasteur MSD’s four-strain influenza vaccine for UK use

July 25, 2016 Manufacturing and Production, Research and Development, Sales and Marketing MHRA, Sanofi pasteur msd, UK, Vaccine, flu, influenza

Sanofi Pasteur MSD has announced the approval of the latest addition to its family of influenza vaccines in the UK: …
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Flawed studies at Semler Research Centre calls for suspension of medicines, EMA recommends

July 25, 2016 Manufacturing and Production, Sales and Marketing EMA, Novartis, Teva, manufacturing, semler

Following an FDA inspection and WHO investigation earlier this year, the European Medicines Agency (EMA) has recommended the suspension of …
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George Scangos to step down as Biogen CEO

July 21, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Biogen, George Scangos

In a surprising move, Biogen used the publishing of some promising second quarter results to announce the departure of CEO …
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Teva sells $15 billion in bonds to fund Allergan generics deal

July 19, 2016 Manufacturing and Production, Sales and Marketing Allergan, Teva, bonds, generics

Teva Pharmaceuticals has announced that it has successfully finalised a bond sale totalling $15 billion that will help to fund …
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Opdivo to go before EU, US regulators in head and neck cancer

July 19, 2016 Manufacturing and Production, Research and Development EMA, EU, FDA, US, head and neck cancer, opdivo

Bristol-Myers Squibb has announced that its lead oncology drug, Opdivo (nivolumab), is set to go before regulators in the US …
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Novartis lowers core operating profit outlook in Q2 results

July 19, 2016 Manufacturing and Production, Research and Development, Sales and Marketing 2016, Novartis, Q2, results

Novartis has warned that its profits may decline this year as it issued second quarter results, with generic competition for …
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New data shows superior viral suppression for Triumeq in women with HIV

July 18, 2016 Manufacturing and Production, Research and Development Triumeq, ViiV Healthcare

ViiV Healthcare has presented late-stage data showing superior efficacy for combination treatment Triumeq (dolutegravir/abacavir/lamivudine) compared with atazanavir, plus other treatments, …
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AstraZeneca presents positive Phase III results for lung cancer drug Tagrisso

July 18, 2016 Manufacturing and Production, Research and Development AstraZeneca, Tagrisso

AstraZeneca has presented results from the latest Phase III trial evaluating Tagrisso (osimertinib) as a second line treatment for patients …
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Amgen agrees deal to commercialise biosimilars in Japan with Daiichi Sankyo

July 14, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Amgen, Daiichi Sankyo, Japan, biosimilars

Amgen (NASDAQ: AMGN) has agreed a deal with Daiichi Sankyo (TSE: 4568) that will see the pair commercialise nine biosimilars …
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AstraZeneca mulling a $10-billion bid for Medivation – report

July 12, 2016 Manufacturing and Production, Sales and Marketing AstraZeneca, Celgene, Medivation, Pfizer, Xtandi, cancer drug, merger and acquisition

Anglo Swedish drug firm AstraZeneca (LSE: AZN) is considering a $10-billion takeover bid for Medivation (Nasdaq: MDVN), according to reports. …
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