On October 26, 2018 Fresenius Kabi reported the immediate availability in the United States of Arsenic Trioxide Injection in a 10 mg per 10 mL vial presentation (Press release, Fresenius, OCT 26, 2018, View Source [SID1234530213]).

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The product is the first-to-market generic of TRISENOX indicated for relapsed or refractory acute promyelocytic leukemia.

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company is a leading developer, manufacturer and provider of injected and infused medicines in the United States with expertise in producing affordable generic alternatives to more expensive brand-name drugs.

"With the introduction of Arsenic Trioxide Injection, Fresenius Kabi is pleased to continue to expand its broad oncology portfolio, providing patients and clinicians with access to affordable generic alternatives of vital medicines," said John Ducker, president and CEO of Fresenius Kabi USA. "We’re also pleased to bring back the 10 mg per 10 mL (1mg per mL) presentation of Arsenic Trioxide Injection – now in a vial – to provide a familiar alternative to clinicians."

About Arsenic Trioxide Injection

Arsenic Trioxide Injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the translocation or PML/RAR-alpha gene expression.

Important Safety Information

WARNING: DIFFERENTIATION SYNDROME AND CARDIAC CONDUCTION ABNORMALITIES

See full prescribing information for complete boxed warning.

Patients treated with Arsenic Trioxide Injection may develop differentiation syndrome, which can be fatal. If symptoms occur, initiate high-dose steroids immediately and monitor hemodynamics.
Arsenic Trioxide Injection can cause QT interval prolongation and ventricular arrhythmia, which can be fatal. Before administering Arsenic Trioxide Injection, assess the QT interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QT interval. Do not administer Arsenic Trioxide Injection to patients with ventricular arrhythmia or prolonged QTcF.
Arsenic Trioxide injection is contraindicated in patients with hypersensitivity to arsenic.

Hepatotoxicity: Monitor hepatic function tests at least twice weekly during arsenic trioxide injection therapy.

Carcinogenesis: Arsenic trioxide is a human carcinogen. Monitor patients for the development of second primary malignancies.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.

Serious adverse reactions reported include: Differentiation Syndrome, cardiac conduction abnormalities, hepatotoxicity, carcinogenesis, and embryo-fetal toxicity. The most common adverse reactions (greater than 30%) were leukocytosis, neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, abdominal pain, hepatic toxicity, fever, rigors, fatigue, insomnia, tachycardia, QTc prolongation, edema, hyperglycemia, hypokalemia, hypomagnesemia, dyspnea, cough, rash or itching, sore throat, arthralgia, headaches, paresthesia and dizziness.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use Arsenic Trioxide Injection safely and effectively. Please see accompanying full prescribing information (View Source) for ARSENIC TRIOXIDE INJECTION, including BOXED WARNING. Full prescribing information is also available at www.fresenius-kabi.co/us.

On October 26, 2018 IntelGenx Technologies Corp. (TSXV:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported that in connection with its previously announced public offering (the "Offering") of units of the Company (the "Units") for aggregate gross proceeds of approximately US$12 million, Echelon Wealth Partners Inc. ("Echelon"), who acted as the Company’s exclusive placement agent in Canada in connection with the Offering, has exercised its option to place a further 903,610 Units pursuant to its over-allotment option (the "Over-Allotment Option"), resulting in additional gross proceeds to the Company of US$632,527 (Press release, IntelGenx, OCT 26, 2018, View Source [SID1234530268]).

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Each Unit was issued at a price of US$0.70 and was comprised of one share of common stock (the "Offered Shares") and one half of one warrant (a "Warrant"), each whole Warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of US$1.00 per share. The Warrants are exercisable immediately and will expire on October 22, 2021.

The Units were distributed under a final prospectus supplement to the U.S. registration statement on Form S-3 (File No. 333-227498) which was declared effective on October 15, 2018 (the "Registration Statement") and a final Canadian MJDS prospectus supplement to the Canadian MJDS short-form base shelf dated October 18, 2018 filed by the Company in connection with the Offering.

Including the net proceeds from the exercise of the Over-Allotment Option, the Company expects the aggregate net proceeds of the Offering to be approximately US$11 million. The Company intends to use the net proceeds from the Offering for its 2a Montelukast Study, its Tadalafil 505(b)(2) submission to the U.S. Food and Drug Administration, and working capital

On October 26, 2018 PharmaMar (MSE:PHM) has reported that the Phase III ATLANTIS trial has received from the Independent Data Monitoring Committee (IDMC) its recommendation that the trial, currently under way with Zepsyre (lurbinectedin, PM1183) in combination with doxorubicin in relapsed small-cell lung cancer patients should continue without any changes. This is the fourth IDMC safety data review that has been passed.

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The IDMC’s recommendation came after having reached the targeted number of 600 patients recruited.

The ATLANTIS trial compares Lurbinectedin plus doxorubicin to physician’s choice of either Topotecan or CAV (cyclophosphamide, adriamycin, vincristine) in a 1 to 1 randomization. The primary endpoint is overall survival, and based on the expected number of events, the results are expected around the end of 2019. The trial is 90% powered to deliver a hazard ratio of 0.75.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On October 26, 2018 Gamida Cell Ltd., a leading cellular and immune therapeutics company, reported the pricing of its initial public offering of 6,250,000 ordinary shares at a public offering price of $8.00 per share for aggregate gross proceeds of $50.0 million (Press release, Gamida Cell, OCT 26, 2018, View Source [SID1234530214]). All of the shares in the offering are being offered by Gamida Cell. In addition, Gamida Cell granted the underwriters a 30-day option to purchase up to 937,500 additional ordinary shares at the initial offering price, less underwriting discounts and commissions. Gamida Cell’s ordinary shares are expected to begin trading on the Nasdaq Global Market on October 26, 2018, under the ticker symbol "GMDA." The offering is expected to close on or about October 30, 2018, subject to customary closing conditions.

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BMO Capital Markets and RBC Capital Markets are acting as joint book-running managers for this offering. Needham & Company and Oppenheimer & Co. are acting as co-lead managers for this offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on October 26, 2018. This offering will be made only by means of a prospectus. Copies of the final prospectus related to this offering may be obtained, when available, from: BMO Capital Markets, 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, Telephone: (800) 414-3627, Email: [email protected]; or RBC Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, Attention: Equity Syndicate Department, Telephone: (877) 822-4089, Email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction

On October 26, 2018 Johnson & Johnson (NYSE: JNJ) reported that the United States District Court, District of New Jersey has issued a ruling invalidating all asserted claims of U.S. Patent No. 8,822,438 for ZYTIGA (abiraterone acetate) (Press release, Johnson & Johnson, OCT 26, 2018, View Source [SID1234530301]). The Court held that the patent claims would be infringed if the patent were valid. The patent infringement case was filed against several companies who have submitted Abbreviated New Drug Applications for 250 mg and/or 500 mg tablets.

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Janssen strongly disagrees with the court’s ruling and will continue to defend the patent. We plan to appeal the decision. The Court has ordered that the status quo be maintained through October 30, 2018, and no generic launch shall occur before October 31, 2018 so that Janssen’s preliminary injunction motion to enjoin defendants from launching their generic products pending the appeal process can be decided. Janssen has filed a motion for rehearing with the U.S. Patent & Trademark Office (USPTO) in connection with the prior Inter Partes Review decisions related to the ‘438 patent.

Commercial launch of generic abiraterone acetate prior to the outcome of the appeals would be considered an at-risk launch. In Europe, ZYTIGA is protected by regulatory exclusivity through September 2022.

Janssen will continue to defend intellectual property rights relating to its innovative medicines. The company reaffirms its guidance provided on October 16, 2018 for operational sales growth of 5.5% to 6.0% and its adjusted earnings per share guidance of $8.13 – $8.18 for the full-year 2018.