Archived News Headlines

We have been archiving all OBR daily news stories since March 2008. Use the box below to search our archives for specific articles and content. Please note: we do not "host" news articles on our website. When a media source removes an article from their website the link becomes inactive, and you will only be able to see the date, title, first sentence and media source that published the article.

Daiichi Sankyo Presents Updated Phase 1 Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Low Expressing Metastatic Breast Cancer at 2018 San Antonio Breast Cancer Symposium (SABCS)

(Daiichi Sankyo) Dec 10, 2018 - Updated analysis from ongoing phase 1 study of [fam-] trastuzumab deruxtecan (DS-8201) demonstrated a confirmed overall response rate of 44.2 percent and a disease control rate of 79.1 percent in 43 evaluable patients with heavily pretreated HER2 low metastatic breast cancer.

Investigation Of Generic ‘Cartel’ Expands To 300 Drugs

(Washington Post) Dec 9, 2018 - Executives at more than a dozen generic-drug companies had a form of shorthand to describe how they conducted business, insider lingo worked out over steak dinners, cocktail receptions and rounds of golf.

MacroGenics Announces Partial Clinical Hold on MGD009 Phase 1 Studies

(NASDAQ) Dec 7, 2018 - MacroGenics, Inc. today announced that on December 6, it received a letter from the U.S. Food and Drug Administration (FDA) indicating that a partial clinical hold has been placed on its Phase 1 monotherapy study of MGD009, a B7-H3 × CD3 bispecific DART® molecule, as well as on a combination study of MGD009 and MGA012 (anti-PD-1). Under the partial clinical hold, no new patients will be enrolled in either study until the partial hold is lifted by the FDA. Current study participants may continue to receive drug at their pre-assigned dose. The partial clinical hold was initiated following MacroGenics' reporting of hepatic adverse events on the MGD009 monotherapy trial to the FDA, including reversible elevations of transaminases with or without concurrent elevations of bilirubin.

Samsung Bioepis Announces Results of Additional One-Year Follow-Up Study Comparing Event-Free Survival of SB3 Trastuzumab Biosimilar Candidate to Reference Trastuzumab by ADCC Activity

(Morningstar) Dec 8, 2018 - Samsung Bioepis Co., Ltd. today announced the results of an additional one-year follow-up study comparing event-free survival (EFS) of SB3, a biosimilar candidate referencing HERCEPTIN® 1 (trastuzumab), to reference trastuzumab (TRZ) by antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

How to Cut Drug Prices: Experts Weigh In

(New York Times/The Upshot blog) Dec 10, 2018 - A look at policies and possible trade-offs, including the risk of hampering innovation.

Merck KGaA, Darmstadt, Germany, Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

(Merck KGaA) Dec 10, 2018 - Merck KGaA, Darmstadt, Germany, a leading science and technology company, which operates its healthcare business in the U.S. and Canada as EMD Serono, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to M7824, the first regulatory designation for the bifunctional immunotherapy, for the treatment of biliary tract cancer (BTC).

The Drug Industry Is Headed Back To Congress To Make Its Case. Will Democrats Keep The Door Open?

(STAT) Dec 10, 2018 - With annual revenues of roughly $450 million and an army of some 160 lobbyists, PhRMA has long been described in near mythological terms by both awed opponents and reverent allies: It’s untouchable, it never loses, it can kill a bill before the ink is dry on the first draft.

Breast Cancer Survivors May Have Lingering Mental Health Effects

(Reuters Health) Dec 7, 2018 - Breast cancer survivors may be more likely to experience anxiety, depression, sleep troubles and other mental health issues than women who have not been diagnosed with the disease, a research review suggests.

‘All I Want For Christmas’ Is The Shingles Vaccine, But It’s Nearly Impossible To Find

(Washington Post) Dec 7, 2018 - A national shortage of a new vaccine to protect against the painful rash known as shingles is worsening, even as the manufacturer announced plans this week to boost deliveries.

Young Age Associated with Worse Prognosis in Specific Breast Cancer Subtype

(Johns Hopkins Medicine) Dec 10, 2018 - A new study of data from breast cancer patients who underwent surgery at The Johns Hopkins Hospital showed age was a strong predictor of disease-free survival for hormone receptor-positive luminal A breast cancer, the most common type of breast cancer.