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    E.g., 2018-02-25

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4:54 PM, Feb 23, 2018  |  BioCentury | Regulation

Herculean task for DMD

Driven by the delayed reimbursement decision for Europe’s only approved DMD therapy, the patient advocacy group Duchenne UK has brought together seven companies in the space to create a set of shared tools that should...
4:51 PM, Feb 23, 2018  |  BioCentury | Strategy

Patients as pawns

In an apparent game of chicken between Vertex Pharmaceuticals Inc. and French health authorities over the price of the cystic fibrosis drug Orkambi, patients say the decision to use access to investigational therapies as a...
4:49 PM, Feb 23, 2018  |  BioCentury | Politics, Policy & Law

Fiddling with Medicare

Looking for ways to fulfill its commitment to reduce drug costs, the Trump administration reached into a grab bag filled with Medicare reforms, pulled out a fist full and dropped them into its FY19 budget...
4:47 PM, Feb 23, 2018  |  BC Extra | Company News

Exact Sciences down on 1Q18 Cologuard guidance

Exact Sciences Corp. (NASDAQ:EXAS) fell $2.62 to $42.37 Friday after providing first quarter projections that suggest it will have to play catch up the rest of the year to meet its 2018 guidance for total...
4:29 PM, Feb 23, 2018  |  BC Extra | Preclinical News

Scientists develop antibody-ligand traps for checkpoint inhibitor-resistant cancers

A study showed a bifunctional antibody-ligand trap compound comprised of a checkpoint inhibitor and an ectodomain sequence from transforming growth factor (TGF) beta receptor II (TGFbeta-RII; TGFBR2) could treat checkpoint inhibitor-resistant cancers. Previous studies showed high...
4:29 PM, Feb 23, 2018  |  BC Extra | Financial News

HKEX reiterates plans to expand listing eligibility for biotechs

Hong Kong Exchanges and Clearing Ltd. (HKEX) published Friday the second round of its consultation paper proposing to amend listing rules to allow pre-revenue biotechs and companies from emerging and innovative sectors with weighted voting...
4:23 PM, Feb 23, 2018  |  BC Extra | Politics & Policy

Neal, Pallone propose Medicare opioid treatment program bill

Reps. Richard Neal (D-Mass.), ranking member of the House Ways and Means Committee, and Frank Pallone (D-N.J.), ranking member of the House Energy and Commerce Committee, introduced a bill to give Medicare patients access to...
4:15 PM, Feb 23, 2018  |  BC Extra | Company News

CHMP backs approval of Mylotarg, Alpivab, Kineret

EMA's CHMP announced a spate of opinions Friday, including positive recommendations for Mylotarg gemtuzumab ozogamicin, Alpivab peramivir and Kineret anakinra, as well as the expected negative opinion for Nerlynx neratinib. The committee recommended approval of Mylotarg...
4:12 PM, Feb 23, 2018  |  BioCentury | Finance

Earnings on deck

Earnings on deck At least four profitable biotechs and pharmas are slated to report earnings this week. CompanyDatePre/post mkt4Q17 EPS est4Q16 EPSExpected chgEndo International plc (NASDAQ:ENDP)2/27Pre$0.61$1.77-66%Jazz Pharmaceuticals plc (NASDAQ:JAZZ)2/27Post$3.01$2.7111%Bayer AG (Xetra:BAYN)2/28Pre€ 1.16€ 1.19-3%Valeant Pharmaceuticals International Inc. (NYSE:VRX;...
2:09 PM, Feb 23, 2018  |  BC Extra | Company News

Priority Review for Shire's HAE prophylactic

FDA accepted and granted Priority Review to a BLA for lanadelumab (SHP643) from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent hereditary angioedema (HAE) attacks in patients ages 12 and older. Its PDUFA date is Aug. 26. The...

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