May 7, 2020 - Fierce Biotech
PTC Therapeutics is adding to its rare disease pipeline with a midstage biotech buyout with a low upfront payment tied in with stock and biobucks.
The company is Censa Pharmaceuticals, a little-known biotech that late last year reported
encouraging data
from a phase 2 study of its asset CNSA-001 (sepiapterin), an experimental med set up for orphan metabolic diseases including phenylketonuria (PKU) .
PKU is a rare, inherited metabolic disorder caused by mutations in the phenylalanine hydroxylase (PAH) gene. Patients with mutations in the PAH gene inefficiently metabolize phenylalanine (Phe), leading to potentially toxic levels of Phe in the blood and serious resulting health problems.
May 7, 2020 - Fierce Pharma
GlaxoSmithKline has offloaded a chunk of its consumer health business in a deal that earned the company more proceeds than expected.
On Thursday, GSK said it sold its entire 5.7% stake in Unilever’s Indian business, known as Hindustan Unilever, for Rs. 254.8 billion ($3.35 billion). The British pharma got its hands on the shares in its divestment of Horlicks drinks and other consumer health nutrition brands to Unilever, a deal that just wrapped up in April.
Size-wise, the deal
topped
another major Indian transaction in recent memory—Daiichi Sankyo’s now-infamous $3.2 billion sale of Ranbaxy Laboratories to Sun Pharma in 2015.
May 5, 2020 - BioPharma Dive
Pfizer and BioNTech on Tuesday
said
the first healthy volunteers have received the companies' coronavirus vaccine in a U.S. trial, following the completion of dosing in a Germany-based study last week.
The U.S. trial will expand to four sites, first testing the vaccine in adults under age 55 and extending to those 65 to 85 once data from the younger enrollees show it's safe and stimulates an immune response to coronavirus. Four different prototypes of the vaccine will be tested in the trial, which will enroll 360 people.
Pfizer and BioNTech expect to have initial data from the trial in late May or June. Pfizer is also preparing to scale up manufacturing to deliver millions of doses by the end of 2020.
May 1, 2020 - FiercePharma
Days after U.S. officials and others reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization.
President Donald Trump and Gilead CEO Daniel O'Day made the announcement Friday afternoon at the White House,
according
to CNBC's Meg Tirrell.
An FDA
fact sheet
on the emergency authorization says there are no FDA-approved products for COVID-19, but that Gilead's drug "may benefit certain people in the hospital." In the FDA's
emergency approval letter
, FDA chief scientist Denise Hinton said the emergency nod is warranted because of the lethal nature of COVID-19 and the lack of approved treatments. The emergency approval is limited to patients with severe disease.
