Piper incrementally positive on Akebia shares, ups target to $22. Piper Jaffray analyst Christopher Raymond is incrementally positive on shares of Akebia Therapeutics after new nephrologist survey data indicated that Auryxia “has not just turned a corner, but is really on quite a roll, both in terms of the drug’s perception and its market share dynamics.” With the stock down 4% since before last month’s merger announcement with Keryx (KERX), Raymond sees a “significant opportunity” to own Akebia before the drug’s near-term share gains and the “real potential of a nephrology powerhouse with both Auryxia and vadadustat, become more apparent.” He raised his price target for the shares to $22 from $20 and keeps an Overweight rating on the name
Thursday, July 12, 2018
Mylan priced Amgen biosimilar at 33% discount, says Jefferies
Jefferies analyst Michael Yee says Mylan (MYL) priced its biosimilar to Amgen’s Neulasta at a 33% discount to the gross price of branded Neulasta. While the discount is slightly more than initial expectations of 10%-20%, the key is knowing what level of rebating Mylan will be offering to hospitals, Yee tells investors in a research note. The analyst admits, however, that Mylan’s Fulphila price “indeed undercuts” Amgen. He keeps a Buy rating on Amgen shares with a $200 price target.
Pfenex gets milestone from Merck with Phase 3 start for vax
Pfenex (PFNX) announced the receipt of a milestone payment from Merck (MRK) associated with the initiation of the first Phase 3 clinical study of, an investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease. Under the agreement, signed in 2007, Pfenex is eligible to receive annual fees, milestone payments, and a tiered royalty based on net sales for all products developed by Merck that use the Pfenex Expression Technology platform.
Loxo target upped by Oppco
Loxo Oncology price target raised to $202 from $122 at Oppenheimer. Oppenheimer analyst Leah Rush Cann raised her price target for Loxo Oncology to $202 from $122 to account for an increased average forward price-to-sales multiple of the biotechnology sector. The analyst reiterates an Outperform rating on the shares.
Wednesday, July 11, 2018
Novartis joins antibiotics exit, dumps research, cuts 140, out-licenses programs
Another Big Pharma is retreating from the antibiotics field.
Novartis today says its early-stage research group at NIBR is dropping antibacterial and antiviral research programs based in Emeryville, CA. And they’re doing it at a time that drug-resistant strains of bacteria are spreading around the world — an issue that once commanded considerable attention at Novartis.
The reorganization will trigger the layoff of about 140 staffers. Novartis noted:
The groups that are impacted in their entirety are antibacterial and antiviral research. As a result, other groups are also affected including, Pharmacology, Protein Sciences, Project Management and global support functions in Global Discovery Chemistry, NIBR Informatics, Scientific Opertions and Translational Medicine. About 150 employees will remain in the San Francisco Bay Area in support of NITD and our drug discovery efforts.
On the chopping block are a group of preclinical programs as well as LYS228, their clinical-stage effort in the field. Most of the affected staffers will have a 60-day period to work out their departure, with severance, while a small group will stay on to handle the shutdown.
Novartis added:
While the science for these programs is compelling, we have decided to prioritize our resources in other areas where we believe we are better positioned to develop innovative medicines that will have a positive impact for patients. The need for these types of medicines is clear and to maximize the chances that these programs will one day help patients we are actively engaged in out-licensing discussions with companies focused on developing medicines in these areas.
This isn’t the first time NIBR has reorganized. There was a considerable revamp shortly after Jay Bradner took the reins at the institutes. And Novartis itself is known for a restless search for cost cuts wherever it can find them — which triggered their decision to scrap a special gene and cell therapy unit and intergrate the group in the main development organization.
Pharma started bailing on antibiotics research years ago, discouraged by the notable absence of profits as generics dominated treatment. That left R&D to a small group of biotechs looking to come up with new approaches that could be used as drug-resistance become increasingly common.
The surviving players will now get a chance to pick over what is being scrapped now, just as AstraZeneca once tried to sell of their unit near Boston — until they were forced to finally spin it off as a new company.
CMS proposes $190 million raise for dialysis centers
CMS proposed boosting dialysis facilities’ pay and changing how the agency pays for durable medical equipment.
In a proposed rule released Wednesday, the CMS made some technical changes to its payment methodology for these providers. The changes will result in a 1.7%, or $190 million, increase in reimbursement. On top of that, dialysis centers should receive an additional $30 million in co-pays from Medicare beneficiaries, bringing their total pay bump to $220 million.
That’s a bigger increase than the $80 million raise dialysis centers received last year.
The agency wants to encourage providers to use new renal dialysis drugs, and proposed paying a higher Medicare rate for the treatments starting Jan. 1, 2019.
In addition, the CMS will make some tweaks to its bidding and pricing methodologies under the durable medical equipment bidding program.
The agency wants to implement what’s known as lead item bidding. Under the current bidding process, suppliers bid to set prices on powered wheelchairs as well as all of its accessories. Under the proposed change, the CMS would only accept bids for the power wheelchair and set prices for accessory items based on a fee schedule.
“This approach will streamline the bidding process for suppliers and ensure pricing is accurate,” Verma said on a call with reporters Wednesday.
The agency said the proposed changes will better help ensure Medicare enrollees get the medical equipment they need.
“Today’s proposals will help secure sustainable access to durable medical equipment and reward dialysis facilities that adopt innovative new therapies,” CMS Administrator Seema Verma said in a statement.
Michigan Says Autism And Arthritis Now Treatable By Medical Marijuana
Michigan has added several medical conditions to the state’s list of ailments which qualify for a medical marijuana prescription.
In a release by Michigan’s Department of Licensing and Regulatory Affairs (LARA), 11 “debilitating medical conditions” including autism, arthritis, Parkinson’s disease, and Tourette’s Syndrome have now been deemed treatable by LARA’s director Shelly Edgerton.
“With the changes in state law to include marihuana-infused products, and the advancement of marihuana research… I’ve added these eleven conditions to the approved list,” Edgerton said in the July 9 release.
The 11 conditions joins other serious illnesses like cancer, glaucoma, and ALS on the state’s approved marijuana list. Michigan’s full list of newly approved ailments includes:
- Arthritis
- Autism
- Chronic Pain
- Colitis
- Inflammatory Bowel Disease
- Obsessive Compulsive Disorder
- Parkinson’s
- Rheumatoid Arthritis
- Spinal Cord Injury
- Tourette’s Syndrome
- Ulcerative Colitis
11 other conditions were denied marijuana treatment by Edgerton. That list included asthma, depression, and diabetes.
“It is definitely opening the doors to be able to help many, many families. I honestly feel like it saved my son’s life,” Amie Carter told WNEM. Carter’s 11-year-old son Jayden has autism and has reportedly had major issues with behavior in the past.
“Because of cannabis oil he hasn’t any encounters with police in over a year, it changed our lives,” Carter added.
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