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Home » Newsletters » BioWorld

BioWorld

Jan. 18, 2017

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Financings

Jounce Therapeutics Inc., of Cambridge, Mass., set terms for its IPO, seeking to raise $75 million by offering 5.36 million common shares priced in a range of $13 to $15. Read More

In the clinic

Protokinetix Inc., of St. Marys, W. Va., said the Governors of the University of Alberta have submitted an investigational testing authorization application to Health Canada to enter a phase I/II trial on PKX-001 in Canada. Read More

Other news to note

Corbus Pharmaceuticals Holdings Inc., of Norwood, Mass., said the European Commission granted orphan designation for its synthetic oral endocannabinoid-mimetic drug, JBT-101, to treat systemic sclerosis. Read More

Regulatory front

Baxter Healthcare Corp., a subsidiary of Deerfield, Ill.-based Baxter International Inc., will pay nearly $18.2 million as part of a deferred prosecution agreement resolving criminal and civil liability arising from drug manufacturing problems at a Marion, N.C., plant. Read More

Tighter regulations in China as vaccine scandals continue

HONG KONG – The sentencing of a former CFDA official to a prison term may be a sign that the country is getting serious about tightening supervision of its vaccine products. Read More

New targets for overcoming melanoma resistance identified

HONG KONG – A study by Japanese researchers has identified two promising and selective candidate therapeutic targets that could prove important in the development of new treatments aimed at overcoming drug resistance in melanoma. Read More

FDA seeks post-start design change in Concert's CF drug trial

Concert Pharmaceuticals Inc. said in order to support dose selection for a future phase III trial of CTP-656 in cystic fibrosis (CF), the FDA will require its ongoing phase II trial to institute a washout period during which Kalydeco (ivacaftor, Vertex Pharmaceuticals Inc.) treatment would be withheld – potentially a hard ask for patients meeting the study's screening criteria of having been on at least three months of stable Kalydeco therapy. Read More

Biopharma in crosshairs as OECD tackles waste in health care spending

LONDON – Health ministers from 35 Organisation for Economic Co-operation and Development (OECD) countries meeting in Paris on Tuesday have pharma and biotech in their sights as they set out plans to cooperate in tackling ineffective health spending and waste. Read More

Alcobra to wind down MDX in ADHD, mull prospects in FXS

Alcobra Ltd. is yanking development of metadoxine extended release (MDX) in the lead indication of attention deficit hyperactivity disorder (ADHD) in adults after the phase III registration trial, MEASURE, failed to demonstrate a statistically significant difference from placebo in change from baseline of the investigator rating of Conners' Adult ADHD Rating Scales, or CAARS, the primary endpoint. Read More

FDA maps out the route to market for interchangeables

At last, the FDA has delivered on its promise to issue guidance on interchangeability, opening the door to automatic pharmacy substitution and the closest thing possible to a generic biologic. Read More

Biogen paying Forward Pharma $1.25B in partial settlement of DMF IP dispute

DUBLIN – Forward Pharma A/S is banking a $1.25 billion cash payment from Biogen Inc. in a partial settlement of their intellectual property dispute over the use of dimethyl fumarate (DMF) for treating multiple sclerosis, and it could also be in line to pocket future royalties from sales of Biogen's Tecfidera product. Read More

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