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BioWorld - Friday, December 26, 2025
Home » Topics » Briefs

Briefs
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Regulatory front

Oct. 15, 2019
After proposing an undisclosed alternative price, Clovis Oncology Inc., of Boulder, Colo., got the approval of the U.K.'s National Institute for Health and Care Excellence (NICE) for coverage of its ovarian cancer drug Rubraca (rucaparib) under the Cancer Drugs Fund (CDF) while the company continues to collect long-term overall survival data.
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Regulatory front

Oct. 14, 2019
The Institute for Clinical and Economic Review (ICER), of Boston, said it released an updated draft evidence report assessing the comparative clinical effectiveness and value of treatments for rheumatoid arthritis.
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Regulatory front

Oct. 11, 2019
The FDA’s Office of Pediatric Therapeutics will hold a public workshop at the agency’s Silver Springs, Md., campus Nov. 12 to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases.
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Regulatory actions for Oct. 10, 2019

Oct. 11, 2019

Other news to note

Oct. 10, 2019
Galderma Pharma SA, of Lausanne, Switzerland, received a manufacturing license from the Swedish Medical Products Agency for a facility in Uppsala, Sweden. The facility will manufacture Galderma's QM-1114, a botulinum toxin derived from a strain of Clostridium botulinum.
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Regulatory front

Oct. 10, 2019
President Donald Trump signed two executive orders Wednesday to improve transparency and fairness in U.S. government agencies and to ensure that they are held accountable. 
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Appointments and advancements

Oct. 10, 2019
Aerie Pharmaceuticals Inc., of Durham, N.C., appointed Charlene E. Davis vice president and chief compliance officer.
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Clinical data for Oct. 9, 2019

Oct. 10, 2019

Financings

Oct. 10, 2019
Sorrento Therapeutics Inc., of San Diego, said it closed its registered direct offering of about 10.9 million shares of common stock and warrants to purchase up to 10.9 million shares, at a combined purchase price of $2.30 per share and related warrant. 
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Other news to note Oct. 1-7, 2019

Oct. 9, 2019
Astellas Pharma Inc., of Tokyo, plans to invest $12.5 million in two innovation incubators operated by Cambridge, Mass.-based Labcentral, which specializes in biotech startups. 
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