Target to $3.50 from $7.50
Wednesday, January 5, 2022
AstraZeneca Transfers Global Rights to Eklira, Duaklir to Covis
AstraZeneca PLC said Wednesday that it has transferred the global rights to Eklira and Duaklir to Covis Pharma Group for a sum of $270 million.
The pharmaceutical giant added that it will also receive payments for certain continuing development costs related to the medicines.
Eklira and Duaklir are inhaled respiratory medicines used to maintain treatment of chronic obstructive pulmonary disease.
AlloVir Gets FDA Regenerative Medicine Advanced Therapy Tag
AlloVir Inc. said the U.S. Food and Drug Administration granted its lead multi-virus specific T cell therapy posoleucel Regenerative Medicine Advanced Therapy designation.
The designation is for the treatment of adenovirus infection following allogeneic hematopoietic stem cell transplant and is based on results from a Phase 2 study.
RMAT designation recognizes the potential for posoleucel to address the unmet medical need posed by AdV, a potentially life-threatening condition with no approved treatment options, the late-clinical stage company said.
This designation enables early interactions with the FDA to discuss clinical trial design and other actions to expedite development and review.
The FDA previously granted RMAT designation to posoleucel for the treatment of hemorrhagic cystitis caused by BK virus in adults and children following allo-HCT.
A Phase 3 study of posoleucel for the treatment of AdV viremia is now enrolling pediatric and adult patients following allo-HCT. This study is the second Phase 3 registrational study of posoleucel.
The company also said it initiated a Phase 1/2 clinical trial of ALVR106 for the treatment of infections caused by human metapneumovirus, influenza, parainfluenza virus and respiratory syncytial virus.
Eagle Pharmaceuticals Shares Turn Positive After Positive 2022 Outlook
Eagle Pharmaceuticals Inc. shares pushed into positive territory Wednesday after the company said it expects significant revenue growth this year.
The stock was up 1% to $51.70 at 1:50 p.m. ET.
The company said it will begin shipping vasopressin on Jan. 17, with 180 days of marketing exclusivity. Vasostrict U.S. sales totaled $890 million for the last 12 months ended Sept. 30.
Eagle said that on Feb. 1, it will launch Pemfexy, a ready-to-use liquid with a unique J-code. Eagle has been building inventory and said it believes this is a significant opportunity, as the Alimta U.S. market totaled $1.2 billion for the last fiscal year.
The company said that based on discussions with the U.S. Food and Drug Administration, it will begin human pilot studies of its fulvestrant product candidate for the treatment of HR+/HER- advanced breast cancer shortly. The company is also on track to submit a new drug application in the first half of 2022, seeking approval of Landiolol, a novel therapeutic for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
"Our already-strong balance sheet and cash position will benefit from the two launches and position us well to deploy our cash strategically through additional in-licensing opportunities, as well as potential acquisitions of companies or products," said Scott Tarriff, chief executive of Eagle Pharmaceuticals.
Shares in COVID-19 vaccine developer Valneva extend fall
Shares in biotech company Valneva fell again on Wednesday, declining for the seventh day in a row due to a growing belief amongst investors that the COVID-19 Omicron variant might lessen the need for mass vaccination.
At 0945 GMT, Valneva shares were down 3% at 17.10 euros, meaning the stock has now lost close to 40% since its Dec. 27 close of 26.38 euros.
It did gain more than 200% a year in 2021 and 2020 as Valneva's COVID-19 vaccine candidate came increasingly closer to approval. It is still awaiting a green light for its shot in the European Union and Britain.
"The decline of the share price seems to be mostly driven by retail investors who think that there will be no need of a new vaccination campaign after the Omicron wave", a Paris-based analyst said.
Companies whose COVID-19 vaccines have already been approved have also seen their shares dip since the start of the year, with Pfizer losing 7.65% over the last two days and Moderna down 8.2%.
Initial data in various countries seem to suggest that Omicron -- the most contagious of all the COVID variants to date with new cases at record levels in many countries -- is less likely to send infected people to hospital.
White House: No plans to change definition of 'fully vaccinated'
The Biden administration said Wednesday it has no plans to change the definition of "fully vaccinated" against the coronavirus to include getting a booster shot.
"Individuals are considered fully vaccinated against COVID-19 if they've received their primary series, that definition is not changing," Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky said at a press briefing.
She said that the CDC is instead using the term "up to date" to encourage people to get boosters.
The definition is important for an array of vaccine requirements the administration has put forward. It means two shots of Pfizer or Moderna will remain enough to satisfy Occupational Safety and Health Administration (OSHA) and Centers for Medicare and Medicaid Services (CMS) mandates for large employers and for health workers.
"Someone is considered fully vaccinated if they have received their primary series of vaccines, so if you think about the different requirements that you mentioned, travel, OSHA, CMS rules and other examples, that has not changed and we do not have any plans to change that," White House COVID-19 response coordinator Jeff Zients said.
The announcement from the White House comes after weeks of questions about the definition and officials saying they were reviewing the issue.
Many health experts have urged the administration to change the definition, noting the importance of booster shots in protecting against infection from the omicron variant.
The Biden administration said it is still urging all adults to get booster shots, it just is not changing the definition for purposes of the mandates.
Zients noted that two doses still provides strong protection against severe disease, though three doses are needed to provide better protection against getting infected at all.
"I do think it's really important to recognize the vast majority of hospitalizations and deaths are among the unvaccinated Americans and completing the primary vaccination series is clearly a critical step to prevent severe outcomes, with boosters, as Dr. Walensky said, giving the highest level of protection," Zients said. "So we will encourage everybody to get vaccinated, and when eligible boosted."
Anthony Fauci, Biden's chief medical adviser, told CNN in December that in his "personal opinion" it was a matter of "when, not if" the definition would change.
He said that the definition aside, "certainly, when you want to talk about what optimal protection is, I don’t think anybody would argue that optimal protection is going to be with a third shot."
Babies born during pandemic showing slight delays in developmental skills
- A new study on babies born during the pandemic found some had lower gross motor, fine motor and social skills than pre-pandemic babies.
- Researchers believe pregnant mothers experiencing pandemic related stress may have caused the drop in developmental scores.
- The lower developmental scores were small shifts in average scores between groups, but researchers emphasized it’s important to pay attention to.
The pandemic has upended normal life for most people, prompting some to lose jobs, attend school from home and limit time spent with friends. Now scientists have discovered that even babies have felt the stress, with some born during the coronavirus pandemic experiencing slight developmental delays.
In , a group of researchers studied 255 infants born between March and December 2020 and found that average developmental scores among babies born during the pandemic, whether their mothers had COVID-19 during pregnancy or not, were lower than the gross motor, fine motor and social skills of 62 pre-pandemic babies.
Dani Dumitriu, assistant professor of pediatrics and psychiatry at Columbia University and lead investigator of the study, suggest the huge amount of stress felt by pregnant mothers during the pandemic may have played a role.
“The developmental trajectory of an infant begins before birth. With potentially millions of infants who may have been exposed to COVID in utero, and even more mothers just living through the stress of the pandemic, there is a critical need to understand the neurodevelopmental effects of the pandemic on future generations,” said Dumitriu.
Last year, Dumitriu, along with a group of pediatric researchers, found that , but this week’s new research indicates instead that the womb of a mother experiencing the pandemic was associated with slightly lower scores in areas like motor and social skills.
Though her particular study didn’t measure maternal stress during pregnancy, previous studies have shown that maternal stress in the earliest stages of pregnancy can have a bigger effect on socioemotional functioning in infants than stress later in pregnancy.
Dumitriu’s study confirmed that fact, finding that infants whose mothers were in the first trimester of pregnancy at the height of the coronavirus pandemic had the lowest neurodevelopment scores.
specifically took on the task of analyzing how stress related to the pandemic impacted pregnant women, finding about 40 percent of women in the study scoring high in depressive symptoms.
However, stress may not be the only factor, with the pandemic limiting social interactions like play dates that may explain the weaker developmental scores of babies born during the pandemic.
Dumitriu emphasized that the lower developmental scores were not huge, just small shifts in average scores between groups, but it’s nonetheless important to pay attention to.
“These small shifts warrant careful attention because at the population level, they can have a significant public health impact. We know this from other pandemics and natural disasters,” said Dumitriu.
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