Walgreens Boots Alliance (NASDAQ:WBA) discloses (10-Q, page 24) that the company met with the U.S. Department of Justice (DOJ) last month concerning alleged violations of the U.S. Controlled Substances Act and the U.S. False Claims Act. The inquiry relates to prescription dispensing at certain Walgreens locations.Walgreens Boots Alliance (NASDAQ:WBA) discloses (10-Q, page 24) that the company met with the U.S. Department of Justice (DOJ) last month concerning alleged violations of the U.S. Controlled Substances Act and the U.S. False Claims Act. The inquiry relates to prescription dispensing at certain Walgreens locations.
Friday, July 10, 2020
Oragenics up on advancement of COVID-19 vaccine program
Oragenics (NYSEMKT:OGEN) is up 13% premarket on the heels of its update on its SARS-CoV-2 vaccine candidate TerraCoV2.
While working with Aragen Bioscience, the National Institutes of Health-created stabilized pre-fusion spike protein gene has been successfully inserted into Chinese hamster cells and mini-pool production and analytical development are underway. The transfer to full-scale manufacturing is expected to commence later this summer.
The company expects TerraCoV2 into human clinical trials by early 2021.
Additionally, Oragenics has decided to terminate clinical development of AG013 for the treatment of severe oral mucositis in cancer patients and withdraw its Investigational New Drug (IND) application. It pulled the plug due overall lack of efficacy, along with other factors.
FDA OKs Amneal generic fluphenazine
Amneal Pharmaceuticals (NYSE:AMRX) announces the FDA nod for its generic version of Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg.
The antipsychotic med was originally marketed under the brand name Prolixin by Bristol-Myers Squibb for the treatment of schizophrenia, since discontinued.
Commercial launch is underway.
Per IQVIA, the U.S. market is ~$143M.
Aytu Bio expands U.S. distribution of COVID-19 blood test with Apollo deal
Aytu BioScience (NASDAQ:AYTU) has signed a distribution agreement with Apollo Med Innovations to distribute its COVID-19 IgG/IgM Rapid Test Cassette to Apollo’s network of over 1,000 practices across the U.S.
Apollo will introduce the test as part of a comprehensive support program for professional medical organizations, integrated wellness centers, employers and municipalities.
Financial terms are not disclosed.
Thursday, July 9, 2020
Allergan: Botox Label Expanded to Treat Pediatric Patients with Spasticity
Allergan on Thursday said the U.S. Food and Drug Administration approved an expansion to the label for Botox, to include “the treatment of spasticity in pediatric patients two years of age and older.”
The company said the label expansion includes those patients “with lower limb spasticity caused by cerebral palsy.”
Botox hasn’t been shown “to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture,” the company said.
Allergan also said, “This label expansion is based on Allergan and another manufacturer selectively waiving orphan exclusivity marketing rights each company held for the use of their respective neurotoxins in the treatment of pediatric patients with spasticity caused by cerebral palsy.”
Allergan is an AbbVie Inc. company.
Post-lockdown: Canada aims to wean people from aid, get them working again
Canada is preparing to dial back emergency income support for people laid off due to COVID-19 in favor of more traditional unemployment benefits and will shift resources to a wage subsidy program that encourage employers to rehire staff.
The income support, paid to individuals, has done its job and the focus must now shift to getting people back to work by making better uses of the wage subsidy program, which is paid to businesses, Finance Minister Bill Morneau said this week.
He promoted the shift after saying Canada would post a historic C$343.2 billion ($252.6 billion) deficit this year.
But Morneau’s job will be tricky. COVID-19 cases are increasing more slowly, but there is a heightened risk of a second wave as the economy reopens. Furthermore, the shift must ensure that people do not end up worse off than they were during the lockdown phase.
For example, the emergency support had few restrictions and most people were eligible, while traditional unemployment criteria are more stringent.
So far, some 8 million people have received as much as C$2,000 ($1,472) per month in emergency cash, but the program expires at the end of August.
“It’s going to be critical for the economy, one way or the other, that we transition Canadians off the (income support) and onto the wage subsidy,” said Colin Guldimann, an economist at the Royal Bank of Canada.
Analysts expect Friday’s job data to show 700,000 new jobs in June, following nearly 300,000 gains in May. But the unemployment rate is seen at 12%, not far below the May record of 13.7%.
Under the wage subsidy program, the federal government gives qualifying businesses 75% of employees’ wages. But critics of the program say the current requirement to have posted a 30% revenue loss is too onerous and may prevent businesses from fully reopening for fear they will lose access to it.
“They have to build into the system a little bit more flexibility for all employers, so if they’re on the program and they have these ups and downs (in revenue), they don’t lose access to the program,” said Hassan Yussuff, Canadian Labor Congress president.
The changes are coming, and they will make the program more flexible for employers and aim to stimulate hiring even uncertainty remains due to COVID-19, Morneau said.
The government on Wednesday set aside C$82.3 billion for the wage subsidy program, some C$64 billion more than it has paid out. By contrast, the income support has cost C$53.5 billion so far, and only an additional C$20 billion has been earmarked for this year.
“The original idea of these programs was to minimize the damage,” said Royce Mendes, senior economist at CIBC Capital Markets. “The new goal is to promote recovery… For that to happen, the government would like to see people get back to work.”
Biotech Investors: Mark Your Calendar For These July PDUFA Dates
The busy calendar of June proved positive for drug approvals, with most scheduled events producing positive outcomes. New molecular entity, or NME, approval for the month totaled two, taking the total NME approvals for the year to 24.
Among the NME approvals was Viela Bio Inc’s VIE 2.06% lead drug Uplinza, which is indicated for neuromyelitis optica spectrum disorder. Although Upliinza will be pitched against Alexion Pharmaceuticals, Inc.’s ALXN 0.44% Soliris, the absence of black box warning gives the former an edge, H.C. Wainwright analyst Raghuram Selvaraju said in a note.
There were disappointments too. Nabriva Therapeutics PLC’s – ADR NBRV 0.19% antibiotic Contepa, as expectedly, was handed down a second complete response letter, or CRL, and AbbVie Inc’s ABBV 1.4% eye disorder drug also faced rejection at the FDA altar.
Here are the key PDUFA dates scheduled for July.
Endo Gets Nod For CCH In Cellulite
- Company: BioSpecifics Technologies Corp. BSTC 3.01% and Endo International PLC ENDP 1.47%
- Type of Application: BLA
- Candidate: collagenase clostridium histolyticum, or CCH
- Indication: for treating cellulite
- Date: July 6
CCH is developed by BioSpecifics and has already been approved for treating Dupuytren’s contracture and Peyronie’s disease in 2010 and 2013, respectively, and it is marketed in the U.S. by its partner Endo.
The original BLA for CCH in cellulitis, was accepted for review Nov. 19, 2019. Cellulite is a localized alteration in the contour of the skin that is reported in 85%-98% of post-pubertal females, caused by a thickening of the collagen septae that attach the skin to the underlying fascia layers with additional contributing protrusions of subcutaneous fat.
The septae tether the skin, causing surface dimpling, and cellulite is present mainly on the buttocks, thighs, lower abdomen and arms.
Endo said in its first-quarter earnings release in May that it is moving its anticipated product launch to the first quarter of 2021 due to medical aesthetics physician office closures and softer consumer spending in the wake of COVID-19.
Can Second Time Be Charm For Eagle Pharma?
- Company: Eagle Pharmaceuticals Inc EGRX 1.88%
- Type of Application: NDA
- Candidate: Ryanodex
- Indication: exertional heat stroke, or EHS.
- Date: July 8
Ryanodex, or dantrolene sodium for injectable suspension, is indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measure. The original NDA for treating EHS was handed down a CRL in July 2017. Eagle resubmitted the application in Jan. 2020.
EHS, a severe form of heat-related illness, is characterized by core body temperature of 104° F or greater, and significant neurological dysfunction, such as sudden changes in behavior, seizures or coma.
“We believe expectations for approval are low; thus, if EGRX is successful in gaining approval on or by the PDUFA date, we would expect this to be positively received given that it would provide upside not fully reflected in current estimates,” Cantor Fitzgerald said in a recent note.
Verrica Seeks Approval For Topical Skin Infection Treatment
- Company: Verrica Pharmaceuticals Inc VRCA 0.45%
- Type of Application: NDA
- Candidate: VP-102
- Indication: treatment of molluscum contagiosum
- Date: July 13
VP-102, or cantharidin 0.7% topical solution, is being evaluated as a potential treatment option for molluscum contagiosum and common warts. Molluscum, according to Verrica, is a highly contagious viral skin infection affecting approximately six million people, primarily children, in the U.S.
Verrica submitted the NDA Sept. 13, 2019, with the FDA accepting the application for review Nov. 26.
H.C. Wainwright analyst Oren Livnat estimates peak sales of about $400 million, assuming that it captures peak share just under 40% of total procedure volume.
Osmotica Seeks FDA Approval For ‘First-of-its-kind’ Treatment Option For Droopy Eyelid
- Company: Osmotica Pharmaceuticals PLC OSMT 10.06%
- Type of Application: NDA
- Candidate: RVL-1201
- Indication: acquired blepharoptosis (droopy eyelid or ptosis)
- Date: July 16
The FDA accepted the regulatory filing for RVL-1201 in November. RVL-1201 is a once-daily ophthalmic formulation of oxymetazoline, a direct-acting α-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller’s muscle and elevate the upper eyelid.
Acquired blepharoptosis, which can be congenital or acquired, is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. The current standard of care is surgery, which is often reserved only for severe cases and may carry an increased risk of adverse events such as infection, bleeding, and asymmetry.
If approved, RVL-1201 will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelid, Osmotica said.
Following an investor call with the management, SunTrust Robinson Humphrey analyst Gregory Fraser noted the company is currently in labeling discussion with the FDA, and expects approval to come by the PDUFA date.
“The company will determine pricing for RVL-1201 closer to launch but is leaning towards the lower end of the $75-100/month range that it has previously discussed,” the analyst said.
Jazz Burns Midnight Oil as Excessive Daytime Sleepiness Drug Nears Decision Day
- Company: Jazz Pharmaceuticals PLC JAZZ 1.93%
- Type of Application: NDA
- Candidate: JZP-258
- Indication: treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy
- Date: July 21
JZP-258 is a novel oxybate product candidate with a unique composition of cations resulting in 92%, or approximately 1,000 to 1,500 milligrams, less sodium than Xyrem, the current standard of care. The NDA was accepted for review on March 25.
GW Pharma Seeks Label Expansion For Epidiolex
- Company: GW Pharmaceuticals PLC- ADR GWPH 0.69%
- Type of Application: sNDA
- Candidate: Epidiolex
- Indication: seizures associated with tuberous sclerosis complex, or TSC
- Date: July 31
Adcom Meeting Schedule
FDA’s Oncologic Drugs Advisory Committee is scheduled to discuss GlaxoSmithKline plc’s GSK 0.91% BLA for belantamab mafodotin as a potential treatment option for relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
The investigational asset is being co-developed with Seattle Genetics, Inc. SGEN 3.21%, which has contributed its antibody-drug conjugate technology. The Adcom meeting is scheduled for Tuesday, July 14.
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