trending Market Intelligence /marketintelligence/en/news-insights/trending/ap_qQn4YGF75-9e44kln3w2 content esgSubNav
In This List

Gottlieb lifts hiring freeze at FDA; Ebola may cross Congo border

Case Study

Identifying PPE Suppliers During the Pandemic

Blog

Highlighting the Top Regional Aftermarket Research Brokers by Sector Coverage

Video

COVID-19 Impact & Recovery: Healthcare Outlook for H2 2021

Blog

Corporate Credit Risk Trends in Developing Markets: A Loss Given Default (LGD) Perspective


Gottlieb lifts hiring freeze at FDA; Ebola may cross Congo border

* In a May 25 House hearing, Scott Gottlieb discussed the need to take on drugmakers exploiting a lack of generic competition. The U.S. Food and Drug Administration's new chief also revealed that he was lifting the hiring freeze on all FDA positions, which President Donald Trump had imposed in January on federal agencies.

* The World Health Organization said that the recent Ebola outbreak in Congo can spread to the neighboring Central African Republic, where militia violence forced thousands to flee across the border, Reuters reported. Four of the 43 suspected and confirmed Ebola patients have died, the publication added.

* Doctors and pharmaceutical executives expressed concern over Indian Prime Minister Narendra Modi's proposed plan to require doctors to only prescribe generic drugs, Reuters reported.

* Republican senators will continue working on their version of the legislation to repeal and replace the Affordable Care Act during the weeklong Memorial Day recess, The Wall Street Journal reported.

* Blue Cross and Blue Shield of North Carolina is planning an average increase of 22.9% in 2018 ACA plans, unless it is guaranteed cost-sharing payments, in which case rates would go up by 8.8%. Meanwhile, Blue Cross & Blue Shield of Kansas City became the latest insurer to exit the ACA health insurance exchanges.

M&A and capital markets

* Aerie Pharmaceuticals Inc. plans to raise $50 million via an underwritten public offering. The funds will help with the commercialization programs of Rhopressa and Roclatan in North America, among other things.

* Achaogen Inc. priced an underwritten public offering of 5 million common shares at $22.50 apiece for gross proceeds of $112.5 million. Achaogen plans to use the net proceeds to develop and prepare its lead product candidate plazomicin, among other things.

Drug and product pipeline

* A proposed biosimilar of Amgen Inc.'s Epogen received the backing of the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee. Pfizer Inc. will market the drug to boost red blood cells in anemic patients with chronic kidney disease, HIV and cancer, pending final approval from the FDA which can take or reject the committee's advice.

* TrovaGene Inc. reported positive results from a phase 1 study of PCM-075 in patients with acute myeloid leukemia. The trial was conducted by Nerviano Medical Sciences.

* BioCryst Pharmaceuticals Inc. disclosed positive results from a second interim analysis of a phase 2 clinical trial evaluating BCX7353 as a preventative treatment to reduce the frequency of attacks in patients with hereditary angioedema. Hereditary angioedema is a rare, autosomal dominantly inherited blood disorder that causes episodic attacks of swelling that may affect the face, extremities, genitals, gastrointestinal tract and upper airways.

* AstraZeneca PLC is recalling one lot of professional sample bottles containing eight tablets of its heart disease drug Brilinta, following a report that a bottle also contained one of its prescription drugs called Zurampic. The company initiated the voluntary recall as a precautionary measure, which is limited to one batch of bottles distributed to physicians in the U.S. between March and April.

Operational activity

* Cipla Ltd. reported a loss of 617.9 million Indian rupees, or 77 paise per share, for the fiscal fourth quarter ended March 31, compared to the year-ago loss of 928.3 million rupees, or 1.15 rupees per share.

* 21st Century Oncology Inc. filed for Chapter 11 protection in the U.S. Bankruptcy Court for the Southern District of New York after reaching an agreement with lenders to restructure more than $500 million in debt. The restructuring provides for a new cash equity infusion of $75 million.

* Merck & Co. Inc. is partnering with Teijin Pharma Ltd. to develop and commercialize an investigational drug to treat Alzheimer's disease.

* The Japan Pharmaceutical Manufacturers Association reinstated the membership status of Novartis AG's Japanese unit. The status was revoked in November 2013 over a data manipulation scandal, The Nikkei reports.

Now featured on S&P Global Market Intelligence:

* Alexion CEO pursues drug pipeline revamp after executive shakeup: The imminent departure of four Alexion Pharmaceuticals executives, the latest in a string of shakeups for the company, is actually a positive sign, according to several analysts optimistic that the company is on a new path.

* UK has strongest, most robust drug pipeline in EU, says BIA: The U.K. is in a strong position to close the gap on leading life sciences clusters like Boston and San Francisco after a "robust" year of investment in the sector from venture capitalists and a string of initial public offerings, according to the latest report from the BioIndustry Association.

* Perrigo's revised earnings show life without Tysabri, calm some investor anxiety: Perrigo Co. PLC's revised 2016 earnings should clear the way for financial compliance and more strategy focus in the year ahead, company executives and an analyst said after Perrigo released its fourth quarter and full-year 2016 earnings May 22.

The day ahead

Early morning futures indicators pointed to a lower opening for the U.S. market.

In Asia, the Hang Seng inched up 0.03% to 25,639.27, while the Nikkei 225 decreased 0.64% to 19,686.84.

In Europe, around midday, the FTSE 100 was up 0.17% to 7,530.74, while the Euronext 100 was down 0.56% to 1,022.37.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.

The Daily Dose, Healthcare edition, will not be published Monday, May 29. We will resume publication Tuesday, May 30.