Vaccine confusion as clots force jab switch for two million

17 June 2021 - Health authorities are scrambling to switch more than two million Australians aged under 60 to the ...

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Amicus Therapeutics announces United Kingdom’s MHRA grants early access to AT-GAA

8 June 2021 - Permits All Eligible Individuals with Late-Onset Pompe Disease Access to AT-GAA Prior to Marketing Authorization in the ...

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Glaukos Announces Australia’s TGA regulatory approval for Preserflo MicroShunt

8 June 2021 - Glaukos Corporation today announced that the TGA has granted regulatory approval for the Preserflo MicroShunt intended for ...

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U.S. FDA approves Prevnar 20, Pfizer’s pneumococcal 20 valent conjugate vaccine for adults ages 18 years or older

8 June 2021 - First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of ...

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Biogen faces tough questions over $56,000 a year price of newly approved Alzheimer’s drug

8 June 2021 - The biotech company’s price for the drug is higher than the $10,000 to $25,000 some Wall Street ...

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Alpha Tau receives breakthrough device designation from the FDA for Alpha DaRT

8 June 2021 - Alpha Tau Medical is pleased to announce that it has received a breakthrough device designation for Alpha ...

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VBI Vaccines granted FDA fast track designation for VBI-1901 for the treatment of recurrent GBM

8 June 2021 - Designation granted based on data from the Phase 1/2a study of VBI-1901 in recurrent GBM patients. ...

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Incyte announces U.S. FDA has extended the sNDA review period for ruxolitinib (Jakafi) in chronic graft versus host disease

8 June 2021 - Incyte today announced that the U.S. FDA has extended the review period for the supplemental new drug ...

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Biogen CEO says $56,000 annually for Alzheimer’s drug is ‘fair,’ promises not to hike price for at least 4 years

7 June 2021 - Biogen CEO Michel Vounatsos told CNBC on Monday that the list price of $56,000 per year ...

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Biogen and Eisai launch multiple initiatives to help patients with Alzheimer’s disease access Aduhelm

7 June 2021 - Value based agreements in progress with Cigna and other payers. ...

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Despite its high price tag, the new Alzheimer’s drug isn’t reigniting the drug pricing debate

8 June 2021 - It has all the makings of a bombastic drug pricing debate: a highly anticipated drug, widespread ...

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BerGenBio receives FDA fast track designation for bemcentinib/anti-PD-(L)1 combination in NSCLC

8 June 2021 - First recognition by a regulator of AXL positive patients as a target population. ...

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Robertson says PHARMAC's bulk buying model is 'different', not 'worse' than other OECD countries

8 June 2021 - The Deputy Prime Minister says the agency’s bulk buying model works for many Kiwis. ...

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NICE recommends Tecentriq for first-line NSCLC

7 June 2021 - NICE has recommended Roche’s Tecentriq (atezolizumab) monotherapy for untreated metastatic non-small cell lung cancer. ...

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FDA’s decision to approve new treatment for Alzheimer’s disease

7 June 2021 - Today FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, ...

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Moderna files for authorisation with Health Canada for its COVID-19 vaccine in adolescents

7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...

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