Pharmaceutical

Avadel Pharmaceuticals (NASDAQ:AVDL) has announced that the US Food and Drug Administration (FDA) has granted the company new drug application for its fourth product, AV001. As quoted in the press release: It has been granted Priority Review status by the FDA resulting in a six-month review period. The FDA has assigned a Prescription Drug User …

Avadel Pharmaceuticals (NASDAQ:AVDL) has announced that the US Food and Drug Administration (FDA) has granted the company new drug application for its fourth product, AV001.

As quoted in the press release:

It has been granted Priority Review status by the FDA resulting in a six-month review period. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 15, 2019.

“If approved, AV001 will be our fourth revenue producing Hospital Product,” said Greg Divis, interim Chief Executive Officer of Avadel. “We are pleased that the FDA has granted AV001 an accelerated 6-month Priority Review. Subsequent to our NDA submission, the FDA granted an NDA approval for a parenteral product with the same Active Pharmaceutical Ingredient (API) as AV001. We will continue to monitor the marketplace as we work with FDA on our application and prepare for a successful launch of AV001.”

Click here to read the full press release.

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Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant while two doses show significantly reduced neutralization titers Data indicate that a third dose of BNT162b2 increases the neutralizing antibody titers by 25-fold compared to two doses against the Omicron variant; titers after the booster dose are comparable to titers observed after two ...
  • Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant (B.1.1.529 lineage) while two doses show significantly reduced neutralization titers
  • Data indicate that a third dose of BNT162b2 increases the neutralizing antibody titers by 25-fold compared to two doses against the Omicron variant; titers after the booster dose are comparable to titers observed after two doses against the wild-type virus which are associated with high levels of protection
  • As 80% of epitopes in the spike protein recognized by CD8+ T cells are not affected by the mutations in the Omicron variant, two doses may still induce protection against severe disease
  • The companies continue to advance the development of a variant-specific vaccine for Omicron and expect to have it available by March in the event that an adaption is needed to further increase the level and duration of protection – with no change expected to the companies' four billion dose capacity for 2022

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an initial laboratory study demonstrating that serum antibodies induced by the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) neutralize the SARS-CoV-2 Omicron variant after three doses. Sera obtained from vaccinees one month after receiving the booster vaccination (third dose of BNT162b2 vaccine) neutralized the Omicron variant to levels that are comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211208005542/en/

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Merck known as MSD outside the United States and Canada, today priced an $8.0 billion public offering of five series of senior unsecured notes . The notes include: $1.5 billion of 1.700% notes due 2027 $1.0 billion of 1.900% notes due 2028 $2.0 billion of 2.150% notes due 2031 $2.0 billion of 2.750% notes due 2051 $1.5 billion of 2.900% notes due 2061 Merck intends to use the net proceeds from the offering of the ...

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today priced an $8.0 billion public offering of five series of senior unsecured notes (collectively, the "notes"). The notes include:

$1.5 billion of 1.700% notes due 2027 (the "2027 notes")

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Pfizer Inc. invites investors and the general public to access a live webcast of a presentation and conference call with investment analysts at 8:30 a.m. EST on Friday, December 17, 2021. Pfizer Vaccines and Hospital leadership will discuss the Pfizer-BioNTech COVID-19 vaccine and Pfizer’s novel COVID-19 oral antiviral treatment candidate. To access the webcast and presentation slides, visit our web site at . ...

Pfizer Inc. (NYSE: PFE) invites investors and the general public to access a live webcast of a presentation and conference call with investment analysts at 8:30 a.m. EST on Friday, December 17, 2021. Pfizer Vaccines and Hospital leadership will discuss the Pfizer-BioNTech COVID-19 vaccine and Pfizer's novel COVID-19 oral antiviral treatment candidate.

To access the webcast and presentation slides, visit our web site at www.pfizer.com/investors . Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance.

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