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Clinical Trials In 2019: Is Biopharma Ready To Tackle The Iron Triangle of Time, Cost and Quality?

The clinical trial embodies the hope and the hassle of biopharma’s mission to develop new drugs for patients. It is an endlessly imperfect process: C-suite calls for more efficiency and speed at lower cost has been the story for decades. But an In Vivo conversation with a leading expert on trial management pinpoints three key trends that suggest better days are ahead for this central pillar of the innovation imperative.

Clinical Trials Innovation BioPharmaceutical
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FDA Sticks To Its Guns On Biosimilar Naming

In the face of calls from the biosimilars industry to rethink its position on biological naming conventions as being out of step with other major territories, the FDA has issued fresh guidance that reinforces its commitment to using four-letter suffixes for both biosimilars and new brand biologics, as well as confirming that the names of any biosimilars designated as ‘interchangeable’ will bear a suffix. At the same time, the agency has rowed back on previous proposals to retroactively add a suffix to already-licensed biologics.

Biosimilars Market Intelligence

Deals Shaping The Medical Industry, March 2019

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced February 2019.

Deals Financing

Deals In Depth: January 2019

Genentech signed a $2.3bn alliance with Adaptive Biotechnologies around neoantigen-directed T-cell therapies. Two major players in the industry, Bristol-Myers Squibb and Celgene, agreed to combine in a $74bn deal. KKR and Viking Global Investors co-led a nearly $300m investment in genetic disease company BridgeBio Pharma.

Deals BioPharmaceutical

AstraZeneca, Novartis Continued Divestment Sprees In 2018, While Peers Joined The Action

While leading large pharma with seven out-licensing or divestiture deals apiece during 2018, AstraZeneca and Novartis each slowed their pace somewhat. But several peer companies followed suit, as there were 31 such deals among the 20 largest biopharma firms last year.

 

Deals M & A

Biopharma Quarterly Dealmaking Statistics, Q4 2018

At $10.9bn, biopharma financing was at its lowest quarter of the year. GSK’s $5.1bn acquisition of oncology player Tesaro led M&As. And 13 partnerships exceeded the $1bn mark, led by two agreements focused on RNAi.

Deals Market Intelligence

Deals Shaping The Medical Industry, February 2019

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the deal-making column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in January 2019.

BioPharmaceutical Medical Device
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