FDA approves Pfizer, Protalix drug for Gaucher disease
NEW YORK — The Food and Drug Administration has approved a new treatment for a rare genetic disorder that affects 10,000 people worldwide.
Pfizer and Protalix BioTherapeutics announced Wednesday the approval of Elelyso (taliglucerase alfa), an enzyme-replacement therapy for the long-term treatment of Type 1 Gaucher disease.
The companies said the drug was the first FDA-approved plant cell-based ERT for Gaucher disease and the first approved plant cell-expressed drug derived from Carmiel, Israel-based Protalix’s ProCellEx manufacturing system, using genetically engineered carrot cells.
"The approval of Elelyso is important for patients who depend on available ERT to manage their Gaucher disease," Protalix president and CEO David Aviezer said. "At Protalix, our passion to develop Elelyso was strongly driven by our personal experience with family members and friends who have to live with this disease every day."
FDA approves generic epilepsy drug from Acella
ATLANTA — The Food and Drug Administration has approved a generic drug for epilepsy made by Acella Pharmaceuticals, the company said Wednesday.
Acella announced the approval of gabapentin oral solution in the 250-mg-per-5-mL strength. The drug is a generic version of Parke Davis’ Neurontin.
"Acella looks forward to adding gabapentin oral solution to our existing line of products as we continue our product development strategy of gaining approval from the FDA and global regulatory agencies for the [abbreviated new drug applications] and [new drug applications] in our pipeline," Acella VP and head of research and development Allen Fields said, referring to the applications used by drug makers to get FDA approval for generic and branded drugs, respectively.
Walgreens expands vaccination offerings across Massachusetts
DEERFIELD, Ill. — With new Massachusetts state regulations allowing pharmacists to administer a broad range of immunizations, Walgreens has significantly expanded vaccine availability at all of its 165 locations across the state, and now is offering immunizations daily for 12 vaccines currently recommended by the Centers for Disease Control and Prevention, the retail pharmacy operator announced Wednesday.
The Massachusetts Department of Public Health approved new regulations in April, giving certified pharmacists the ability to administer a variety of vaccines including Zostavax — a one-time vaccine that can reduce the risk of shingles in individuals ages 60 years and older — and other vaccines that can help protect against whooping cough (pertussis), pneumonia and meningitis. Eight other CDC-recommended vaccinations, including flu shots, also are available daily at all Massachusetts Walgreens pharmacies with no appointment necessary.
“With more than 26,000 immunizations-trained pharmacists, we’ve demonstrated through flu season and other health initiatives the important role Walgreens can play in providing convenient neighborhood access to immunizations and other preventive healthcare services,” Walgreens market pharmacy director Steve Pashko said. “As some of the most trusted health care professionals in communities across our state, this is an excellent opportunity for our pharmacists to help educate residents about the importance of adult vaccinations and collaborate further with our local healthcare providers to help improve adult immunization rates in our communities.”
The full list of vaccines available for adults 18 years of age and older, include:
Tetanus, diphtheria, pertussis (Td/Tdap);
Human papillomavirus (HPV);
Measles, mumps, rubella (MMR);
Pneumococcal polysaccharide vaccine (PSV23);
Hepatitis B; and
Inactivated Polio Vaccine (IPV).