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49993 items
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...
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...
2:06 PM, Feb 23, 2018  |  BC Extra | Company News

Darzalex guidance buoys Genmab shares

Genmab A/S (CSE:GEN; Pink:GMXAY) gained DKK13.6 billion ($2.3 billion) in market cap across two days of trading after issuing an earnings report that included new 2018 guidance for multiple myeloma (MM) drug Darzalex daratumumab. Based...
2:04 PM, Feb 23, 2018  |  BC Extra | Company News

Japan approves Shionogi's single-dose flu treatment

Shionogi & Co. Ltd. (Tokyo:4507) said Japan's Ministry of Health, Labour and Welfare (MHLW) approved an NDA for Xofluza baloxavir marboxil (S-033188), the company's single-dose oral therapy to treat influenza types A and B. The...
12:30 PM, Feb 23, 2018  |  BC Extra | Company News

XLH therapy burosumab gains EU approval

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said the European Commission granted conditional approval to an MAA for Crysvita burosumab (KRN23, UX023) to treat X-linked hypophosphatemia with radiographic evidence of...
11:53 AM, Feb 23, 2018  |  BC Extra | Politics & Policy

CDER schedules third workshop for patient advocacy groups

FDA’s Center for Drug Evaluation and Research will hold a public workshop on April 3 on how to engage effectively with the center. The workshop, entitled “CDER and You: Keys to Effective Engagement,” will feature...