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Takeda reaches preliminary deal to buy Shire for close to $65B

Takeda has upped its offer to buy Shire $SHPG for a mix of stock and cash worth close to $65 billion, which is good enough for the Lexington, MA-based biotech to extend the deadline on their talks to May 8 after determining they were close to finalizing a pact.

Source: endpts
666
April 25, 2018

Autolus announces license agreement with UCL Business PLC for clinical-stage product candidate in development for the treatment of B-cell malignancies

- A CD19 CAR with novel targeting properties designed to reduce cytokine release syndrome –

Source: autolus
588
April 25, 2018

B-cell malignancies Market Views T-cell therapies

FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate. While the Advisory Committee unanimously supported the efficacy of the 4-mg dose of baricitinib, it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.

Source: prnewswire
682
April 25, 2018

baricitinib Eli Lilly New Approvals RA

UCB snags an NDA-ready epilepsy drug from Proximagen in $370M deal

UCB is beefing up its pipeline of epilepsy drugs with an NDA-ready therapy from Proximagen. The Belgian company has agreed to buy their nasal spray therapy USL261, designed as a rescue therapy for acute repetitive seizures, for $150 million in cash and another $220 million in sales and regulatory milestones.

Source: endpts
578
April 25, 2018

acute repetitive seizures Market Views Proximagen UCB

‘Orangeworm’ hacking campaign hits X-ray and MRI machines

Malware from a newly disclosed hacking campaign has infected the networks of multinational health care companies, including some X-ray and MRI machines, cybersecurity firm Symantec warned Monday.

Source: CyberScoop
735
April 25, 2018

cybersecurity Market Views

New partnership announced to prepare Australian GPs for the national expansion of My Health Record

GPs will be actively involved in the delivery of the Federal Government’s My Health Record, with a new partnership designed to train doctors in the use of the national online health information repository and prepare them to answer patients’ questions.

Source: Healthcare IT
551
April 25, 2018

healthcare Market Views

UCSD launching pilot trial of glucose-sensing ‘tattoo’

Researchers from the University of California San Diego have developed a low-cost, single-use tattoo-like wearable that measures the user’s glucose levels. According to a release from the institution, this noninvasive technology will be at the center of a newly announced pilot clinical trial designed to test the accuracy and acceptability of the tattoos.

Source: MobiHealthNews
603
April 25, 2018

blood glucose Researches

Inventiva Raises €35.5 Million Through A Capital Increase With European And US Investors

Inventiva S.A. ("Inventiva" or the "Company"), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announces the successful completion of the issuance of 5,572,500 new ordinary shares without preferential subscription rights (the "New Shares") for a total gross proceeds of approximately €35.5 million by means of a private placement reserved to a specified category of investors as described below (the "Reserved Offering"). The Reserved Offering was conducted by Jefferies International Limited, acting as Global Coordinator and Joint Bookrunner, and Société Générale Corporate & Investment Banking and Gilbert Dupont acting as Joint Bookrunners (together with the Global Coordinator and Joint Bookrunner, the "Managers"). Namsen Capital acted as Inventiva's Capital Markets Advisor.

Source: drugdu
606
April 24, 2018

Market Views MPS NASH Series SSc

FDA ‘conflicted’ on Lilly and Incyte’s refiled baricitinib

Eli Lilly and Incyte’s second attempt to get U.S. approval of rheumatoid arthritis drug baricitinib could be scuppered again by lingering FDA concerns about safety. A briefing document published ahead of the April 23 advisory committee meeting on baricitinib suggests that Lilly and Incyte’s lightning-fast amendment and refile of the dossier hasn’t added enough data to persuade the FDA to change its stance on the risk of blood clots with the JAK inhibitor.

Source: Fiercebiotech; new approvals
619
April 24, 2018

baricitinib Eli Lilly FDA rheumatoid arthritis

Next year’s flu shot will shield only 20% against dominant strain

Recent doubts about traditional egg-based flu shots could mean more business for vaccines manufactured in cells. Protection against the dominant H3N2 flu strain offered by the coming season’s flu vaccine will still be far from optimal—putting it mildly. And that's thanks to the widely used manufacturing process based on eggs, a new study predicts.

Source: fiercepharma
668
April 24, 2018

H3N2 flu strain Researches vaccine

Takeda reaches preliminary deal to buy Shire for close to $65B

Autolus announces license agreement with UCL Business PLC for clinical-stage product candidate in development for the treatment of B-cell malignancies

FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis

UCB snags an NDA-ready epilepsy drug from Proximagen in $370M deal

‘Orangeworm’ hacking campaign hits X-ray and MRI machines

New partnership announced to prepare Australian GPs for the national expansion of My Health Record

UCSD launching pilot trial of glucose-sensing ‘tattoo’

Inventiva Raises €35.5 Million Through A Capital Increase With European And US Investors

FDA ‘conflicted’ on Lilly and Incyte’s refiled baricitinib

Next year’s flu shot will shield only 20% against dominant strain

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